{
  "FullStudy":{
    "Rank":217900,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01515371",
          "OrgStudyIdInfo":{
            "OrgStudyId":"MRZ 60201-2069-1"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"2011-001779-38",
                "SecondaryIdType":"EudraCT Number"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"Merz Pharmaceuticals GmbH",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Dose Finding Study for a Botulinum Toxin Type A Injection to Treat Habitual Snoring",
          "OfficialTitle":"Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group, 3-stage Dose-finding Study to Identify a Safe and Effective Dose of NT 201 for Unilateral Injection Into the Soft Palate for Treatment of Habitual Snoring"
        },
        "StatusModule":{
          "StatusVerifiedDate":"June 2013",
          "OverallStatus":"Terminated",
          "WhyStopped":"Due to lack of sufficient eligible subjects, no safety concerns",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"September 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"November 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 18, 2012",
          "StudyFirstSubmitQCDate":"January 18, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 24, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"June 18, 2013",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"June 19, 2013",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Merz Pharmaceuticals GmbH",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to identify out of up to three doses a safe and effective dose of Botulinum toxin type A for an injection into one side of the soft palate to treat snoring."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Habitual Snoring"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 2"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Double",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Investigator"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"8",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"IncobotulinumtoxinA (Xeomin) 2.5 Units [U], 5U and 7.4U",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"IncobotulinumtoxinA (Xeomin, also known as \"NT 201\" or \"Botulinum toxin type A (150 kiloDalton), free from complexing proteins\") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: IncobotulinumtoxinA"
                  ]
                }
              },{
                "ArmGroupLabel":"Placebo Comparator",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupDescription":"Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Placebo Comparator"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"IncobotulinumtoxinA",
                "InterventionDescription":"Subject to receive one injection of either 2.5U, 5U or 7.4U of IncobotulinumtoxinA.\n\nFor three dose stages: solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), reconstitution volume 8 ml, 4 ml and 2.7 ml per 50U vial, respectively, resulting in a concentration of 6.25 U/ml, 12.5 U/ml and 18.5 U/ml. Injection volume is 0.4 ml for all three dose stages. Mode of administration: unilateral soft palate injection.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "IncobotulinumtoxinA (Xeomin) 2.5 Units [U], 5U and 7.4U"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Placebo Comparator",
                "InterventionDescription":"For three dose stages: solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), reconstitution volume 8 ml, 4 ml and 2.7 ml per vial, respectively. Injection volume is 0.4 ml for all three dose stages. Mode of administration: unilateral soft palate injection.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Placebo Comparator"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Relative change from baseline in Snoring Index at week 4",
                "PrimaryOutcomeDescription":"Snoring Index",
                "PrimaryOutcomeTimeFrame":"Baseline to week 4"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Absolute change from baseline in Snoring Index at week 4",
                "SecondaryOutcomeTimeFrame":"Baseline to week 4"
              },{
                "SecondaryOutcomeMeasure":"Bed partner satisfaction",
                "SecondaryOutcomeDescription":"Bed partner satisfaction to assess the global effect of the treatment.",
                "SecondaryOutcomeTimeFrame":"Week 4"
              },{
                "SecondaryOutcomeMeasure":"Change from baseline in loudness at week 4.",
                "SecondaryOutcomeDescription":"Sone is employed as the unit of the perceived loudness.",
                "SecondaryOutcomeTimeFrame":"Baseline to week 4"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nFemale or male subjects aged 18-70\nSubjects suffering from snoring for at least 3 months prior to the study start and seeking for help to treat snoring\nSubjects with a peak Snoring Index [SI] ≥ 15/ hour of sleep [h] at baseline visit\nSubjects with a bed partner for at least three months prior to study start.\nSubjects who understand the nature of the study and provide written Informed Consent at screening visit.\nSubjects who understand the study procedures as well as possess the ability and willingness to abide by all procedures during the course of the study\n\nExclusion Criteria:\n\nObese subjects (Body Mass Index ≥ 30)\nSubjects with severe obstructive sleep apnea syndrome\nSubjects with Apnea-Hypopnea Index ≥ 10 /hour of sleep and/ or Respiratory Disturbance Index ≥ 25 / hour of sleep at the baseline visit\nSubjects who have undergone any Botulinum neurotoxin treatment in the history\nSubjects with generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome)\nAcute infections of the pharynx",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"70 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Medical Expert",
                "OverallOfficialAffiliation":"Merz Pharmaceuticals GmbH",
                "OverallOfficialRole":"Study Chair"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Merz Investigational Site #049294",
                "LocationCity":"Regensburg",
                "LocationZip":"93053",
                "LocationCountry":"Germany"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"C000545476",
                "InterventionMeshTerm":"incobotulinumtoxinA"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000009465",
                "InterventionAncestorTerm":"Neuromuscular Agents"
              },{
                "InterventionAncestorId":"D000018373",
                "InterventionAncestorTerm":"Peripheral Nervous System Agents"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              },{
                "InterventionAncestorId":"D000065087",
                "InterventionAncestorTerm":"Acetylcholine Release Inhibitors"
              },{
                "InterventionAncestorId":"D000049990",
                "InterventionAncestorTerm":"Membrane Transport Modulators"
              },{
                "InterventionAncestorId":"D000045504",
                "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action"
              },{
                "InterventionAncestorId":"D000018678",
                "InterventionAncestorTerm":"Cholinergic Agents"
              },{
                "InterventionAncestorId":"D000018377",
                "InterventionAncestorTerm":"Neurotransmitter Agents"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M258642",
                "InterventionBrowseLeafName":"incobotulinumtoxinA",
                "InterventionBrowseLeafAsFound":"IncobotulinumtoxinA",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M2054",
                "InterventionBrowseLeafName":"Acetylcholine",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M19342",
                "InterventionBrowseLeafName":"Cholinergic Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M19088",
                "InterventionBrowseLeafName":"Neurotransmitter Agents",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              },{
                "InterventionBrowseBranchAbbrev":"VaDiAg",
                "InterventionBrowseBranchName":"Vasodilator Agents"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000012913",
                "ConditionMeshTerm":"Snoring"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000012135",
                "ConditionAncestorTerm":"Respiratory Sounds"
              },{
                "ConditionAncestorId":"D000012818",
                "ConditionAncestorTerm":"Signs and Symptoms, Respiratory"
              },{
                "ConditionAncestorId":"D000012816",
                "ConditionAncestorTerm":"Signs and Symptoms"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M14299",
                "ConditionBrowseLeafName":"Snoring",
                "ConditionBrowseLeafAsFound":"Snoring",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M13555",
                "ConditionBrowseLeafName":"Respiratory Sounds",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M14206",
                "ConditionBrowseLeafName":"Signs and Symptoms, Respiratory",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}