{ "FullStudy":{ "Rank":217554, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01519882", "OrgStudyIdInfo":{ "OrgStudyId":"SP0919" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"2011-000056-42", "SecondaryIdType":"EudraCT Number" } ] }, "Organization":{ "OrgFullName":"UCB Pharma", "OrgClass":"INDUSTRY" }, "BriefTitle":"Sleep Efficiency Assessed by Polysomnography (PSG Sleep Lab Testing) in Advanced Parkinson's Disease", "OfficialTitle":"A Multi-Centre, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Effects of Rotigotine on Sleep Efficiency in Patients With Advanced Parkinson's Disease.", "Acronym":"REFRESH-PD" }, "StatusModule":{ "StatusVerifiedDate":"January 2014", "OverallStatus":"Terminated", "WhyStopped":"Due to major recruitment issues, a decision was made to terminate this trial", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"March 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"December 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"January 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 24, 2012", "StudyFirstSubmitQCDate":"January 26, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 27, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"December 10, 2013", "ResultsFirstSubmitQCDate":"December 10, 2013", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"January 28, 2014", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 29, 2014", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"March 3, 2014", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"UCB Pharma SA", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"This is a phase 4 study to evaluate with Polysomnography (PSG) and subjective measures the effect of Rotigotine on sleep efficiency, maintenance, insomnia, nocturnal akinesia and night-time movement in bed, in patients with advanced Parkinson's disease." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Advanced Idiopathic Parkinson's Disease" ] }, "KeywordList":{ "Keyword":[ "Rotigotine", "Neupro", "Polysomnography", "Sleep efficiency", "Advanced Idiopathic Parkinson's Disease", "Sleep Disorder" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Quadruple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"1", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Placebo", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"Placebo Transdermal Patches", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: Placebo" ] } },{ "ArmGroupLabel":"Rotigotine", "ArmGroupType":"Experimental", "ArmGroupDescription":"Rotigotine Transdermal Patches", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: Rotigotine" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Other", "InterventionName":"Placebo", "InterventionDescription":"Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.\n\nOptimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo" ] } },{ "InterventionType":"Other", "InterventionName":"Rotigotine", "InterventionDescription":"Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.\n\nOptimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Rotigotine" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Neupro®", "(6S)-6-propyl-[2-(2-thienyl)ethyl]amino-5,6,7,8-tetrahydro-1-naphthalenol" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Percentage Change From Baseline in Sleep Efficiency Index (SEI) to Week 4 of the Maintenance Period", "PrimaryOutcomeDescription":"The Sleep Efficiency Index in percent is the ratio of total sleep time (based on Polysomnography recordings) to time in bed (period between \"lights off\" and \"lights on\").", "PrimaryOutcomeTimeFrame":"From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Change From Baseline in the Parkinson's Disease Sleep Scale Score Version 2 (PDSS2) to Day 1 of the Maintenance Period", "SecondaryOutcomeDescription":"The PDSS is a scale to assess sleep and nocturnal disability in Parkinson's Disease during the previous 7 days, and is designed for self-completion by the subject. The updated version (PDSS2) contains 15 questions to be answered using a 5-point Likert scale, where 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, and 4 = very often.\n\nThus, PDSS2 score ranges from 0-60, with higher scores indicating worse sleep and higher nocturnal disability. A negative value in Change from Baseline indicates improved sleep and less nocturnal disability.", "SecondaryOutcomeTimeFrame":"From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline)" },{ "SecondaryOutcomeMeasure":"Change From Baseline in the Parkinson's Disease Sleep Scale Score Version 2 (PDSS2) to Week 4 of the Maintenance Period", "SecondaryOutcomeDescription":"The PDSS2 is a scale to assess sleep and nocturnal disability in Parkinson's Disease during the previous 7 days, and is designed for self-completion by the subject. The updated version (PDSS2) contains 15 questions to be answered using a 5-point Likert scale, where 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, and 4 = very often.\n\nThus, PDSS2 score ranges from 0-60, with higher scores indicating worse sleep and higher nocturnal disability. A negative value in Change from Baseline indicates improved sleep and less nocturnal disability.", "SecondaryOutcomeTimeFrame":"From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)" },{ "SecondaryOutcomeMeasure":"Change From Baseline in the Epworth Sleepiness Score (ESS) to Day 1 of the Maintenance Period", "SecondaryOutcomeDescription":"The ESS measures the subject's general level of daytime sleepiness. The 8 items of this scale assess the probability of falling asleep in a variety of situations. Each item is scored by the subject using the following categories:\n\n0 = would never doze, 1 = slight chance of dozing, 2 = moderate chance of dozing, and 4 = high chance of dozing.\n\nThe ESS score ranges from 0 to 32, with higher values indicating a higher level of daytime sleepiness. A negative value in Change from Baseline indicates a decrease in daytime sleepiness.", "SecondaryOutcomeTimeFrame":"From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline)" },{ "SecondaryOutcomeMeasure":"Change From Baseline in the Epworth Sleepiness Score (ESS) to Week 4 of the Maintenance Period", "SecondaryOutcomeDescription":"The ESS measures the subject's general level of daytime sleepiness. The 8 items of this scale assess the probability of falling asleep in a variety of situations. Each item is scored by the subject using the following categories:\n\n0 = would never doze, 1 = slight chance of dozing, 2 = moderate chance of dozing, and 4 = high chance of dozing.\n\nThe ESS score ranges from 0 to 32, with higher values indicating a higher level of daytime sleepiness. A negative value in Change from Baseline indicates a decrease in daytime sleepiness.", "SecondaryOutcomeTimeFrame":"From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)" },{ "SecondaryOutcomeMeasure":"Change From Baseline in the Sleep Period Time in Non-Rapid Eye Movement (Non-REM) Sleep to Week 4 of the Maintenance Period", "SecondaryOutcomeDescription":"Polysomnography (PSG) was performed for the 2 consecutive nights prior to Day 1 and the 2 consecutive nights prior Week 4 of the Maintenance Period.\n\nReadings from the first night of the PSG will not be used for analysis as this is considered an adaptation night.\n\nThe subject was not allowed to sleep during the daytime on the day of a PSG reading. The PSG was recorded for a minimum of 6 h and a maximum of 8 h.\n\nThe sleep period time in stage 3 non-REM was derived from the hypnogram, based on Electroencephalogram (EEG), Electro-myogram (EMG), Electro-oculogram (EOG) and Electrocardiogram (ECG). Change from Baseline is calculated by:\n\n(Stage 3 non-REM time (in minutes) at Baseline)- (Stage 3 non-REM time (in minutes) at Week 4 of the MP).", "SecondaryOutcomeTimeFrame":"From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)" },{ "SecondaryOutcomeMeasure":"Change From Baseline in the Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) to Day 1 of the Maintenance Period", "SecondaryOutcomeDescription":"The NADCS assesses nocturnal akinesia, dystonia, and cramps using an ordinal severity scale. While a score of 0 = normal and 4 = maximal severity, subjects can also rate their symptoms with values of 0.5, 1.5, 2.5, and 3.5. The nocturnal akinesia score was used to evaluate motor performance while the dystonia and cramps score was used to evaluate pain. A negative value in Change from Baseline indicates an improvement.", "SecondaryOutcomeTimeFrame":"From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline)" },{ "SecondaryOutcomeMeasure":"Change From Baseline in the Nocturnal Akinesia, Dystonia and Cramps Score (NADCS) to Week 4 of the Maintenance Period", "SecondaryOutcomeDescription":"The NADCS assesses nocturnal akinesia, dystonia, and cramps using an ordinal severity scale. While a score of 0 = normal and 4 = maximal severity, subjects can also rate their symptoms with values of 0.5, 1.5, 2.5, and 3.5. The nocturnal akinesia score was used to evaluate motor performance while the dystonia and cramps score was used to evaluate pain. A negative value in Change from Baseline indicates an improvement.", "SecondaryOutcomeTimeFrame":"From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)" },{ "SecondaryOutcomeMeasure":"Change From Baseline in the Total Wake Time After Sleep Onset (WASO) to Week 4 of the Maintenance Period", "SecondaryOutcomeDescription":"Polysomnography (PSG) was performed for the 2 consecutive nights prior to Day 1 and the 2 consecutive nights prior Week 4 of the Maintenance Period.\n\nReadings from the first night of the PSG will not be used for analysis as this is considered an adaptation night.\n\nThe subject was not allowed to sleep during the daytime on the day of a PSG reading. The PSG was recorded for a minimum of 6 h and a maximum of 8 h.\n\nSleep stages and time spent in each sleep stage were determined from EEG readings. WASO was calculated by:\n\n(Time in bed (Period between \"lights off\" and \"lights on\"))-(Sleep time).", "SecondaryOutcomeTimeFrame":"From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)" },{ "SecondaryOutcomeMeasure":"Change From Baseline in the Total Number of Turnings in Bed to Week 4 of the Maintenance Period", "SecondaryOutcomeDescription":"Polysomnography (PSG) was performed for the 2 consecutive nights prior to Day 1 and the 2 consecutive nights prior Week 4 of the Maintenance Period.\n\nReadings from the first night of the PSG will not be used for analysis as this is considered an adaptation night.\n\nThe subject was not allowed to sleep during the daytime on the day of a PSG reading. The PSG was recorded for a minimum of 6 h and a maximum of 8 h.\n\nThe number of turnings in bed was determined via a postural sensor placed on the subject's chest.", "SecondaryOutcomeTimeFrame":"From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nAdvanced Parkinson's disease (ie, takes Levodopa (L-DOPA))\nHoehn and Yahr stage score of 2 to 4\nSubject has sleep-maintenance insomnia\n\nExclusion Criteria:\n\nSignificant skin disease that would make transdermal drug use inappropriate\nSubject received therapy with controlled-release Levodopa (L-DOPA), entacapone or Stalevo® within 28 days prior to the Baseline Visit or has received therapy with Tolcapone\nAtypical Parkinsonian syndromes\nPrevious diagnosis of Narcolepsy, Sleep Apnoea Syndrome, significant Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD), moderate to severe Restless Legs Syndrome (RLS) or Periodic Limb Movement Disorder", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"UCB Clinical Trial Call Center", "OverallOfficialAffiliation":"+1 877 822 9493 (UCB)", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"1", "LocationCity":"Middlesborough", "LocationCountry":"United Kingdom" } ] } }, "ReferencesModule":{ "SeeAlsoLinkList":{ "SeeAlsoLink":[ { "SeeAlsoLinkLabel":"FDA Safety Alerts and Recalls", "SeeAlsoLinkURL":"http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"1 subjects was randomized to Placebo and started and completed the study (from Screening (Week 0) to the Safety Follow-Up Visit (Week 18)).", "FlowRecruitmentDetails":"The study started in March 2012 and was conducted in the United Kingdom. It was terminated due to recruitment issues in January 2013.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Placebo", "FlowGroupDescription":"Placebo Transdermal Patches\n\nPlacebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.\n\nOptimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Rotigotine", "FlowGroupDescription":"Rotigotine Transdermal Patches\n\nRotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.\n\nOptimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"1" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"1" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Placebo", "BaselineGroupDescription":"Placebo Transdermal Patches\n\nPlacebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.\n\nOptimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day." },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Rotigotine", "BaselineGroupDescription":"Rotigotine Transdermal Patches\n\nRotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.\n\nOptimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day." },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"1" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"0" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"1" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Categorical", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"<=18 years", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } } ] } },{ "BaselineClassTitle":"Between 18 and 65 years", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } } ] } },{ "BaselineClassTitle":">=65 years", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"1" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"67", "BaselineMeasurementSpread":"NA", "BaselineMeasurementComment":"The mean presented here is the individual age of the only subject included." },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"67", "BaselineMeasurementSpread":"NA", "BaselineMeasurementComment":"The mean presented here is the individual age of the only subject included." } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Gender", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Female", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"1" } ] } } ] } },{ "BaselineClassTitle":"Male", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"United Kingdom", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"1" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Percentage Change From Baseline in Sleep Efficiency Index (SEI) to Week 4 of the Maintenance Period", "OutcomeMeasureDescription":"The Sleep Efficiency Index in percent is the ratio of total sleep time (based on Polysomnography recordings) to time in bed (period between \"lights off\" and \"lights on\").", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"percentage change", "OutcomeMeasureTimeFrame":"From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Placebo Transdermal Patches\n\nPlacebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.\n\nOptimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Rotigotine", "OutcomeGroupDescription":"Rotigotine Transdermal Patches\n\nRotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.\n\nOptimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"1" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"0" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4.7", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"The mean presented here is the individual percentage change in SEI (from Baseline to Week 4 of the Maintenance Period) of the only subject included." } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in the Parkinson's Disease Sleep Scale Score Version 2 (PDSS2) to Day 1 of the Maintenance Period", "OutcomeMeasureDescription":"The PDSS is a scale to assess sleep and nocturnal disability in Parkinson's Disease during the previous 7 days, and is designed for self-completion by the subject. The updated version (PDSS2) contains 15 questions to be answered using a 5-point Likert scale, where 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, and 4 = very often.\n\nThus, PDSS2 score ranges from 0-60, with higher scores indicating worse sleep and higher nocturnal disability. A negative value in Change from Baseline indicates improved sleep and less nocturnal disability.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Placebo Transdermal Patches\n\nPlacebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.\n\nOptimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Rotigotine", "OutcomeGroupDescription":"Rotigotine Transdermal Patches\n\nRotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.\n\nOptimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"1" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"0" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"The mean presented here is the individual change in PDSS2 (from Baseline to Day 1 of the Maintenance Period) of the only subject included." } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in the Parkinson's Disease Sleep Scale Score Version 2 (PDSS2) to Week 4 of the Maintenance Period", "OutcomeMeasureDescription":"The PDSS2 is a scale to assess sleep and nocturnal disability in Parkinson's Disease during the previous 7 days, and is designed for self-completion by the subject. The updated version (PDSS2) contains 15 questions to be answered using a 5-point Likert scale, where 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, and 4 = very often.\n\nThus, PDSS2 score ranges from 0-60, with higher scores indicating worse sleep and higher nocturnal disability. A negative value in Change from Baseline indicates improved sleep and less nocturnal disability.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Placebo Transdermal Patches\n\nPlacebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.\n\nOptimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Rotigotine", "OutcomeGroupDescription":"Rotigotine Transdermal Patches\n\nRotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.\n\nOptimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"1" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"0" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"The mean presented here is the individual change in PDSS2 (from Baseline to Week 4 of the Maintenance Period) of the only subject included." } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in the Epworth Sleepiness Score (ESS) to Day 1 of the Maintenance Period", "OutcomeMeasureDescription":"The ESS measures the subject's general level of daytime sleepiness. The 8 items of this scale assess the probability of falling asleep in a variety of situations. Each item is scored by the subject using the following categories:\n\n0 = would never doze, 1 = slight chance of dozing, 2 = moderate chance of dozing, and 4 = high chance of dozing.\n\nThe ESS score ranges from 0 to 32, with higher values indicating a higher level of daytime sleepiness. A negative value in Change from Baseline indicates a decrease in daytime sleepiness.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Placebo Transdermal Patches\n\nPlacebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.\n\nOptimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Rotigotine", "OutcomeGroupDescription":"Rotigotine Transdermal Patches\n\nRotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.\n\nOptimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"1" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"0" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"The mean presented here is the individual change in ESS (from Baseline to Day 1 of the Maintenance Period) of the only subject included." } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in the Epworth Sleepiness Score (ESS) to Week 4 of the Maintenance Period", "OutcomeMeasureDescription":"The ESS measures the subject's general level of daytime sleepiness. The 8 items of this scale assess the probability of falling asleep in a variety of situations. Each item is scored by the subject using the following categories:\n\n0 = would never doze, 1 = slight chance of dozing, 2 = moderate chance of dozing, and 4 = high chance of dozing.\n\nThe ESS score ranges from 0 to 32, with higher values indicating a higher level of daytime sleepiness. A negative value in Change from Baseline indicates a decrease in daytime sleepiness.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Placebo Transdermal Patches\n\nPlacebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.\n\nOptimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Rotigotine", "OutcomeGroupDescription":"Rotigotine Transdermal Patches\n\nRotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.\n\nOptimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"1" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"0" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"The mean presented here is the individual change in ESS (from Baseline to Week 4 of the Maintenance Period) of the only subject included." } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in the Sleep Period Time in Non-Rapid Eye Movement (Non-REM) Sleep to Week 4 of the Maintenance Period", "OutcomeMeasureDescription":"Polysomnography (PSG) was performed for the 2 consecutive nights prior to Day 1 and the 2 consecutive nights prior Week 4 of the Maintenance Period.\n\nReadings from the first night of the PSG will not be used for analysis as this is considered an adaptation night.\n\nThe subject was not allowed to sleep during the daytime on the day of a PSG reading. The PSG was recorded for a minimum of 6 h and a maximum of 8 h.\n\nThe sleep period time in stage 3 non-REM was derived from the hypnogram, based on Electroencephalogram (EEG), Electro-myogram (EMG), Electro-oculogram (EOG) and Electrocardiogram (ECG). Change from Baseline is calculated by:\n\n(Stage 3 non-REM time (in minutes) at Baseline)- (Stage 3 non-REM time (in minutes) at Week 4 of the MP).", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"minutes", "OutcomeMeasureTimeFrame":"From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Placebo Transdermal Patches\n\nPlacebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.\n\nOptimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Rotigotine", "OutcomeGroupDescription":"Rotigotine Transdermal Patches\n\nRotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.\n\nOptimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"1" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"0" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"22", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"The mean presented here is the individual change in sleep Period time in Non-REM sleep (from Baseline to Week 4 of the Maintenance Period) of the only subject included." } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in the Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) to Day 1 of the Maintenance Period", "OutcomeMeasureDescription":"The NADCS assesses nocturnal akinesia, dystonia, and cramps using an ordinal severity scale. While a score of 0 = normal and 4 = maximal severity, subjects can also rate their symptoms with values of 0.5, 1.5, 2.5, and 3.5. The nocturnal akinesia score was used to evaluate motor performance while the dystonia and cramps score was used to evaluate pain. A negative value in Change from Baseline indicates an improvement.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Placebo Transdermal Patches\n\nPlacebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.\n\nOptimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Rotigotine", "OutcomeGroupDescription":"Rotigotine Transdermal Patches\n\nRotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.\n\nOptimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"1" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"0" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.5", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"The mean presented here is the individual change in NADCS (from Baseline to Day 1 of the Maintenance Period) of the only subject included." } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in the Nocturnal Akinesia, Dystonia and Cramps Score (NADCS) to Week 4 of the Maintenance Period", "OutcomeMeasureDescription":"The NADCS assesses nocturnal akinesia, dystonia, and cramps using an ordinal severity scale. While a score of 0 = normal and 4 = maximal severity, subjects can also rate their symptoms with values of 0.5, 1.5, 2.5, and 3.5. The nocturnal akinesia score was used to evaluate motor performance while the dystonia and cramps score was used to evaluate pain. A negative value in Change from Baseline indicates an improvement.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Placebo Transdermal Patches\n\nPlacebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.\n\nOptimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Rotigotine", "OutcomeGroupDescription":"Rotigotine Transdermal Patches\n\nRotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.\n\nOptimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"1" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"0" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.5", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"The mean presented here is the individual change in NADCS (from Baseline to Week 4 of the Maintenance Period) of the only subject included." } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in the Total Wake Time After Sleep Onset (WASO) to Week 4 of the Maintenance Period", "OutcomeMeasureDescription":"Polysomnography (PSG) was performed for the 2 consecutive nights prior to Day 1 and the 2 consecutive nights prior Week 4 of the Maintenance Period.\n\nReadings from the first night of the PSG will not be used for analysis as this is considered an adaptation night.\n\nThe subject was not allowed to sleep during the daytime on the day of a PSG reading. The PSG was recorded for a minimum of 6 h and a maximum of 8 h.\n\nSleep stages and time spent in each sleep stage were determined from EEG readings. WASO was calculated by:\n\n(Time in bed (Period between \"lights off\" and \"lights on\"))-(Sleep time).", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"minutes", "OutcomeMeasureTimeFrame":"From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Placebo Transdermal Patches\n\nPlacebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.\n\nOptimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Rotigotine", "OutcomeGroupDescription":"Rotigotine Transdermal Patches\n\nRotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.\n\nOptimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"1" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"0" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"20", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"The mean presented here is the individual change in total Wake Time After Sleep Onset (from Baseline to Week 4 of the Maintenance Period) of the only subject included." } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in the Total Number of Turnings in Bed to Week 4 of the Maintenance Period", "OutcomeMeasureDescription":"Polysomnography (PSG) was performed for the 2 consecutive nights prior to Day 1 and the 2 consecutive nights prior Week 4 of the Maintenance Period.\n\nReadings from the first night of the PSG will not be used for analysis as this is considered an adaptation night.\n\nThe subject was not allowed to sleep during the daytime on the day of a PSG reading. The PSG was recorded for a minimum of 6 h and a maximum of 8 h.\n\nThe number of turnings in bed was determined via a postural sensor placed on the subject's chest.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Number of turnings in bed", "OutcomeMeasureTimeFrame":"From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Placebo Transdermal Patches\n\nPlacebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.\n\nOptimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Rotigotine", "OutcomeGroupDescription":"Rotigotine Transdermal Patches\n\nRotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.\n\nOptimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"1" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"0" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0", "EventsTimeFrame":"Adverse Events were collected from Baseline to the Safety Follow-Up Visit at Week 18.", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Placebo", "EventGroupDescription":"Placebo Transdermal Patches\n\nPlacebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.\n\nOptimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day.", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"1", "EventGroupOtherNumAffected":"1", "EventGroupOtherNumAtRisk":"1" },{ "EventGroupId":"EG001", "EventGroupTitle":"Rotigotine", "EventGroupDescription":"Rotigotine Transdermal Patches\n\nRotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.\n\nOptimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day.", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"0", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"0" } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Constipation", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA (9.1)", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"1" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"0" } ] } },{ "OtherEventTerm":"Rhinitis", "OtherEventOrganSystem":"Infections and infestations", "OtherEventSourceVocabulary":"MedDRA (9.1)", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"1" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"0" } ] } },{ "OtherEventTerm":"Vertigo", "OtherEventOrganSystem":"Ear and labyrinth disorders", "OtherEventSourceVocabulary":"MedDRA (9.1)", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"1" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"0" } ] } },{ "OtherEventTerm":"Lethargy", "OtherEventOrganSystem":"Nervous system disorders", "OtherEventSourceVocabulary":"MedDRA (9.1)", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"1" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"0" } ] } },{ "OtherEventTerm":"Tension Headache", "OtherEventOrganSystem":"Nervous system disorders", "OtherEventSourceVocabulary":"MedDRA (9.1)", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"1" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"0" } ] } } ] } }, "MoreInfoModule":{ "LimitationsAndCaveats":{}, "CertainAgreement":{ "AgreementPISponsorEmployee":"No", "AgreementRestrictionType":"GT60", "AgreementRestrictiveAgreement":"Yes" }, "PointOfContact":{ "PointOfContactTitle":"UCB Clinical Trial Call Center", "PointOfContactOrganization":"UCB", "PointOfContactPhone":"+1 877 822 9493 (UCB)" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"C000047508", "InterventionMeshTerm":"Rotigotine" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000018491", "InterventionAncestorTerm":"Dopamine Agonists" },{ "InterventionAncestorId":"D000015259", "InterventionAncestorTerm":"Dopamine Agents" },{ "InterventionAncestorId":"D000018377", "InterventionAncestorTerm":"Neurotransmitter Agents" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M261505", "InterventionBrowseLeafName":"Rotigotine", "InterventionBrowseLeafAsFound":"Rotigotine", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M6056", "InterventionBrowseLeafName":"Dopamine", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19179", "InterventionBrowseLeafName":"Dopamine Agonists", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M16545", "InterventionBrowseLeafName":"Dopamine Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19088", "InterventionBrowseLeafName":"Neurotransmitter Agents", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"CaAg", "InterventionBrowseBranchName":"Cardiotonic Agents" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000010300", "ConditionMeshTerm":"Parkinson Disease" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000020734", "ConditionAncestorTerm":"Parkinsonian Disorders" },{ "ConditionAncestorId":"D000001480", "ConditionAncestorTerm":"Basal Ganglia Diseases" },{ "ConditionAncestorId":"D000001927", "ConditionAncestorTerm":"Brain Diseases" },{ "ConditionAncestorId":"D000002493", "ConditionAncestorTerm":"Central Nervous System Diseases" },{ "ConditionAncestorId":"D000009422", "ConditionAncestorTerm":"Nervous System Diseases" },{ "ConditionAncestorId":"D000009069", "ConditionAncestorTerm":"Movement Disorders" },{ "ConditionAncestorId":"D000019636", "ConditionAncestorTerm":"Neurodegenerative Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M14279", "ConditionBrowseLeafName":"Sleep Wake Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M11796", "ConditionBrowseLeafName":"Parkinson Disease", "ConditionBrowseLeafAsFound":"Parkinson's Disease", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M20826", "ConditionBrowseLeafName":"Parasomnias", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M21078", "ConditionBrowseLeafName":"Parkinsonian Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M24190", "ConditionBrowseLeafName":"Ganglion Cysts", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M14941", "ConditionBrowseLeafName":"Synovial Cyst", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3355", "ConditionBrowseLeafName":"Basal Ganglia Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3786", "ConditionBrowseLeafName":"Brain Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4325", "ConditionBrowseLeafName":"Central Nervous System Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10612", "ConditionBrowseLeafName":"Movement Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M20142", "ConditionBrowseLeafName":"Neurodegenerative Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC10", "ConditionBrowseBranchName":"Nervous System Diseases" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"BXM", "ConditionBrowseBranchName":"Behaviors and Mental Disorders" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC04", "ConditionBrowseBranchName":"Cancers and Other Neoplasms" },{ "ConditionBrowseBranchAbbrev":"BC17", "ConditionBrowseBranchName":"Skin and Connective Tissue Diseases" } ] } } } } } }