{ "FullStudy":{ "Rank":217721, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01517698", "OrgStudyIdInfo":{ "OrgStudyId":"NP27936" }, "Organization":{ "OrgFullName":"Hoffmann-La Roche", "OrgClass":"INDUSTRY" }, "BriefTitle":"A Study of RO4917523 in Patients With Fragile X Syndrome", "OfficialTitle":"A Randomized, Double-blind, 12-week, Parallel Group, Placebo-controlled Study of Efficacy and Safety of RO4917523 in Patients With Fragile X Syndrome." }, "StatusModule":{ "StatusVerifiedDate":"July 2016", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"May 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"April 2014", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"April 2014", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 20, 2012", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "DispFirstSubmitDate":"July 6, 2016", "DispFirstSubmitQCDate":"July 6, 2016", "DispFirstPostDateStruct":{ "DispFirstPostDate":"July 11, 2016", "DispFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"July 6, 2016", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"July 11, 2016", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Hoffmann-La Roche", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{}, "DescriptionModule":{ "BriefSummary":"This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will investigate the efficacy and safety of RO4917523 in adolescent and adult patients with fragile X syndrome. Patients will be randomized to receive oral doses of 0.5 mg or 1.5 mg of RO4917523, or matching placebo once daily. The anticipated time on study treatment is 12 weeks." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Fragile X Syndrome" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Double", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"185", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"RO4917523 0.5 mg", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: RO4917523 0.5 mg" ] } },{ "ArmGroupLabel":"RO4917523 1.5 mg", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: RO4917523 1.5 mg" ] } },{ "ArmGroupLabel":"Placebo", "ArmGroupType":"Placebo Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Placebo" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Placebo", "InterventionDescription":"placebo to RO4917523 orally once a day for 12 weeks", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo" ] } },{ "InterventionType":"Drug", "InterventionName":"RO4917523 0.5 mg", "InterventionDescription":"0.5 mg orally once a day for 12 weeks", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "RO4917523 0.5 mg" ] } },{ "InterventionType":"Drug", "InterventionName":"RO4917523 1.5 mg", "InterventionDescription":"1.5 mg orally once a day for 12 weeks", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "RO4917523 1.5 mg" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Change in Anxiety Depression and Mood Scale (ADAMS) total score", "PrimaryOutcomeTimeFrame":"12 weeks" },{ "PrimaryOutcomeMeasure":"Safety (incidence of adverse events)", "PrimaryOutcomeTimeFrame":"12 weeks" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Change in Social Responsiveness Scale (SRS)", "SecondaryOutcomeTimeFrame":"12 weeks" },{ "SecondaryOutcomeMeasure":"Change in Clinical Global Impressions Scale - Improvement (CGI-I)", "SecondaryOutcomeTimeFrame":"12 weeks" },{ "SecondaryOutcomeMeasure":"Change in Clinical Global Impressions Scale - Severity of Illness (CGI-S)", "SecondaryOutcomeTimeFrame":"12 weeks" },{ "SecondaryOutcomeMeasure":"Change in Aberrant Behavior Checklist total score", "SecondaryOutcomeTimeFrame":"12 weeks" },{ "SecondaryOutcomeMeasure":"Change in Aberrant Behavior Checklist factor scores", "SecondaryOutcomeTimeFrame":"12 weeks" },{ "SecondaryOutcomeMeasure":"Change in Anxiety Depression and Mood Scale (ADAMS) factor scores", "SecondaryOutcomeTimeFrame":"12 weeks" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nAdult and adolescent patients, 14-50 years of age\nDiagnosis of fragile X syndrome with a confirmed fragile X mental retardation 1 (FMR1) full mutation and qualifying scores on the Aberrant Behavior Checklist (ABC) and CGI-S\nPatients must agree to either remain completely abstinent or to use two effective contraceptive methods during and 3 weeks after the study\n\nExclusion Criteria:\n\nPrevious treatment with another metabotropic glutamate (mGLU) receptor antagonist within 18 months or with RO4917523\nParticipation in a clinical trial involving an investigational (unapproved) drug within 3 months or 5 times the half-life (whichever is longer) before start of this study\nAny uncontrolled, unstable clinically significant psychiatric condition other than fragile X syndrome\nHistory of suicidal behavior", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"14 Years", "MaximumAge":"50 Years", "StdAgeList":{ "StdAge":[ "Child", "Adult" ] } 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