{"protocolSection":{"identificationModule":{"nctId":"NCT01331109","orgStudyIdInfo":{"id":"MLN-MD-29"},"organization":{"fullName":"Forest Laboratories","class":"INDUSTRY"},"briefTitle":"Long-Term Safety and Efficacy Study of Milnacipran in Pediatric Patients With Primary Fibromyalgia","officialTitle":"A Multicenter, Open-label, 52-Week Extension Study to Evaluate the Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia","acronym":"MyFi"},"statusModule":{"statusVerifiedDate":"2013-07","overallStatus":"TERMINATED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2011-04"},"primaryCompletionDateStruct":{"date":"2012-08","type":"ACTUAL"},"completionDateStruct":{"date":"2012-08","type":"ACTUAL"},"studyFirstSubmitDate":"2011-03-31","studyFirstSubmitQcDate":"2011-04-06","studyFirstPostDateStruct":{"date":"2011-04-07","type":"ESTIMATED"},"resultsFirstSubmitDate":"2013-07-31","resultsFirstSubmitQcDate":"2013-07-31","resultsFirstPostDateStruct":{"date":"2013-09-30","type":"ESTIMATED"},"lastUpdateSubmitDate":"2013-07-31","lastUpdatePostDateStruct":{"date":"2013-09-30","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Forest Laboratories","class":"INDUSTRY"},"collaborators":[{"name":"Cypress Bioscience, Inc.","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"The purpose of this study is to evaluate the long-term safety and efficacy of milnacipran in pediatric patients aged 13 to 17 years with primary fibromyalgia."},"conditionsModule":{"conditions":["Primary Fibromyalgia"],"keywords":["Fibromyalgia","Pediatric Fibromyalgia","Adolescent Fibromyalgia","milnacipran","Savella","loss of therapeutic response","Forest Research Institute","Pain","Fatigue","Serotonin Norepinephrine Reuptake Inhibitors"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":57,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Milnacipran","type":"EXPERIMENTAL","description":"oral administration, twice daily dosing","interventionNames":["Drug: Milnacipran"]}],"interventions":[{"type":"DRUG","name":"Milnacipran","description":"maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks.","armGroupLabels":["Milnacipran"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Adverse Events","description":"Number of Patients who experience one or more treatment emergent adverse event (TEAE)","timeFrame":"Baseline (Visit 1) to Week 53 (Visit 9)"}],"otherOutcomes":[{"measure":"Number of Patients Who Experienced Level 5 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).","description":"The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:\n\n* Level 1: Wish to be Dead\n* Level 2: Non-Specific Active Suicidal Thoughts\n* Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act\n* Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan\n* Level 5: Active Suicidal Ideation with Specific Plan and Intent","timeFrame":"Baseline (Visit 1) to Week 53 (Visit 9)"},{"measure":"Number of Patients Who Experienced Level 4 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).","description":"The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:\n\n* Level 1: Wish to be Dead\n* Level 2: Non-Specific Active Suicidal Thoughts\n* Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act\n* Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan\n* Level 5: Active Suicidal Ideation with Specific Plan and Intent","timeFrame":"Baseline (Visit 1) to Week 53 (Visit 9)"},{"measure":"Number of Patients Who Experienced Level 3 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).","description":"The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:\n\n* Level 1: Wish to be Dead\n* Level 2: Non-Specific Active Suicidal Thoughts\n* Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act\n* Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan\n* Level 5: Active Suicidal Ideation with Specific Plan and Intent","timeFrame":"Baseline (Visit 1) to Week 53 (Visit 9)"},{"measure":"Number of Patients Who Experienced Level 2 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).","description":"The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:\n\n* Level 1: Wish to be Dead\n* Level 2: Non-Specific Active Suicidal Thoughts\n* Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act\n* Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan\n* Level 5: Active Suicidal Ideation with Specific Plan and Intent","timeFrame":"Baseline (Visit 1) to Week 53 (Visit 9)"},{"measure":"Number of Patients Who Experienced Level 1 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).","description":"The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:\n\n* Level 1: Wish to be Dead\n* Level 2: Non-Specific Active Suicidal Thoughts\n* Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act\n* Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan\n* Level 5: Active Suicidal Ideation with Specific Plan and Intent","timeFrame":"Baseline (Visit 1) to Week 53 (Visit 9)"},{"measure":"Number of Patients Who Experienced Any Suicidal Behavior as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS)","description":"The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal behaviors as defined by the eC-SSRS are:\n\n* Preparatory acts or behavior\n* Aborted attempt\n* Interrupted attempt\n* Actual attempt\n* Completed suicide attempt","timeFrame":"Baseline (Visit 1) to Week 53 (Visit 9)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Patients must have completed or discontinued prematurely from lead-in study, MLN-MD-14, tolerating a minimum daily dose of 50mg milnacipran\n\nExclusion Criteria:\n\n* Can not tolerate a minimum daily dose of 50mg milnacipran\n* Significant risk of suicidality\n* Pregnant or breastfeeding","healthyVolunteers":false,"sex":"ALL","minimumAge":"13 Years","maximumAge":"17 Years","stdAges":["CHILD"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Patricia M D'Astoli, LPN","affiliation":"Forest Laboratories","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Forest Investigative Site 040","city":"Birmingham","state":"Alabama","zip":"35205","country":"United 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Preliminary experience using milnacipran in patients with juvenile fibromyalgia: lessons from a clinical trial program. Pediatr Rheumatol Online J. 2015 Jun 26;13:27. doi: 10.1186/s12969-015-0025-9."}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Milnacipran","description":"oral administration, twice daily dosing\n\nMilnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"57"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"57"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"6"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"2"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"3"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"7"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"1"}]},{"type":"Study Terminated by Sponsor","reasons":[{"groupId":"FG000","numSubjects":"38"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All demographic data was based on the safety population, which consists of 57 patients who took at least 1 dose of open-label milnacipran.","groups":[{"id":"BG000","title":"Milnacipran","description":"oral administration, twice daily dosing\n\nMilnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"57"}]}],"measures":[{"title":"Age Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"15.4","spread":"1.35"}]}]}]},{"title":"Age, Customized","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"13 years old","categories":[{"measurements":[{"groupId":"BG000","value":"5"}]}]},{"title":"14 years old","categories":[{"measurements":[{"groupId":"BG000","value":"12"}]}]},{"title":"15 years old","categories":[{"measurements":[{"groupId":"BG000","value":"11"}]}]},{"title":"16 years old","categories":[{"measurements":[{"groupId":"BG000","value":"12"}]}]},{"title":"17 years old","categories":[{"measurements":[{"groupId":"BG000","value":"17"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"50"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"7"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"57"}]}]}]},{"title":"Maximum Tolerated Dose of Milnacipran","description":"Maximum tolerated daily dose of milnacipran.","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Less than 50mg","categories":[{"measurements":[{"groupId":"BG000","value":"0"}]}]},{"title":"50 mg","categories":[{"measurements":[{"groupId":"BG000","value":"3"}]}]},{"title":"75 mg","categories":[{"measurements":[{"groupId":"BG000","value":"8"}]}]},{"title":"100mg","categories":[{"measurements":[{"groupId":"BG000","value":"46"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"OTHER_PRE_SPECIFIED","title":"Number of Patients Who Experienced Level 5 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).","description":"The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:\n\n* Level 1: Wish to be Dead\n* Level 2: Non-Specific Active Suicidal Thoughts\n* Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act\n* Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan\n* Level 5: Active Suicidal Ideation with Specific Plan and Intent","populationDescription":"57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Baseline (Visit 1) to Week 53 (Visit 9)","groups":[{"id":"OG000","title":"Milnacipran","description":"oral administration, twice daily dosing\n\nMilnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"57"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Number of Patients Who Experienced Level 4 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).","description":"The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:\n\n* Level 1: Wish to be Dead\n* Level 2: Non-Specific Active Suicidal Thoughts\n* Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act\n* Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan\n* Level 5: Active Suicidal Ideation with Specific Plan and Intent","populationDescription":"57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Baseline (Visit 1) to Week 53 (Visit 9)","groups":[{"id":"OG000","title":"Milnacipran","description":"oral administration, twice daily dosing\n\nMilnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"57"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]}]},{"type":"PRIMARY","title":"Adverse Events","description":"Number of Patients who experience one or more treatment emergent adverse event (TEAE)","populationDescription":"57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Baseline (Visit 1) to Week 53 (Visit 9)","groups":[{"id":"OG000","title":"Milnacipran","description":"oral administration, twice daily dosing\n\nMilnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"57"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"42"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Number of Patients Who Experienced Level 3 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).","description":"The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:\n\n* Level 1: Wish to be Dead\n* Level 2: Non-Specific Active Suicidal Thoughts\n* Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act\n* Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan\n* Level 5: Active Suicidal Ideation with Specific Plan and Intent","populationDescription":"57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Baseline (Visit 1) to Week 53 (Visit 9)","groups":[{"id":"OG000","title":"Milnacipran","description":"oral administration, twice daily dosing\n\nMilnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"57"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Number of Patients Who Experienced Level 2 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).","description":"The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:\n\n* Level 1: Wish to be Dead\n* Level 2: Non-Specific Active Suicidal Thoughts\n* Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act\n* Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan\n* Level 5: Active Suicidal Ideation with Specific Plan and Intent","populationDescription":"57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Baseline (Visit 1) to Week 53 (Visit 9)","groups":[{"id":"OG000","title":"Milnacipran","description":"oral administration, twice daily dosing\n\nMilnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"57"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Number of Patients Who Experienced Level 1 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).","description":"The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:\n\n* Level 1: Wish to be Dead\n* Level 2: Non-Specific Active Suicidal Thoughts\n* Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act\n* Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan\n* Level 5: Active Suicidal Ideation with Specific Plan and Intent","populationDescription":"57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Baseline (Visit 1) to Week 53 (Visit 9)","groups":[{"id":"OG000","title":"Milnacipran","description":"oral administration, twice daily dosing\n\nMilnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"57"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Number of Patients Who Experienced Any Suicidal Behavior as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS)","description":"The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal behaviors as defined by the eC-SSRS are:\n\n* Preparatory acts or behavior\n* Aborted attempt\n* Interrupted attempt\n* Actual attempt\n* Completed suicide attempt","populationDescription":"57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Baseline (Visit 1) to Week 53 (Visit 9)","groups":[{"id":"OG000","title":"Milnacipran","description":"oral administration, twice daily dosing\n\nMilnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"57"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Adverse Event data was collected during a 14-month period from July, 2011 to August, 2012.","eventGroups":[{"id":"EG000","title":"Milnacipran","description":"oral administration, twice daily dosing\n\nMilnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks.","seriousNumAffected":2,"seriousNumAtRisk":57,"otherNumAffected":28,"otherNumAtRisk":57}],"seriousEvents":[{"term":"Cholecystitis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedRDA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":57}]},{"term":"Suicidal Ideation","organSystem":"Psychiatric disorders","sourceVocabulary":"MedRDA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":57}]}],"otherEvents":[{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedRDA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":57}]},{"term":"Decreased appetite","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedRDA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":57}]},{"term":"Tachycardia","organSystem":"Cardiac disorders","sourceVocabulary":"MedRDA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":57}]},{"term":"Urinary tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedRDA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":57}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedRDA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":57}]},{"term":"Abdominal pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedRDA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":57}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedRDA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":57}]},{"term":"Heart rate increased","organSystem":"Investigations","sourceVocabulary":"MedRDA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":57}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedRDA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":57}]},{"term":"Hepatic enzyme increased","organSystem":"Investigations","sourceVocabulary":"MedRDA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":57}]},{"term":"Oropharyngeal pain","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedRDA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":57}]},{"term":"Weight decreased","organSystem":"Investigations","sourceVocabulary":"MedRDA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":57}]},{"term":"Weight increased","organSystem":"Investigations","sourceVocabulary":"MedRDA 15.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":57}]}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"This study was terminated early, resulting in a small number of patients analyzed. Only descriptive statistics were presented."},"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"OTHER","restrictiveAgreement":true,"otherDetails":"All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study. Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc."},"pointOfContact":{"title":"Robert Palmer, MD","organization":"Forest Research Institute","email":"robert.palmer@frx.com","phone":"1-201-427-8200","phoneExt":"8218"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D005356","term":"Fibromyalgia"},{"id":"D010146","term":"Pain"},{"id":"D005221","term":"Fatigue"}],"ancestors":[{"id":"D009135","term":"Muscular Diseases"},{"id":"D009140","term":"Musculoskeletal Diseases"},{"id":"D012216","term":"Rheumatic Diseases"},{"id":"D009468","term":"Neuromuscular Diseases"},{"id":"D009422","term":"Nervous System Diseases"},{"id":"D009461","term":"Neurologic Manifestations"},{"id":"D012816","term":"Signs and Symptoms"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"}]},"interventionBrowseModule":{"meshes":[{"id":"D000078764","term":"Milnacipran"}],"ancestors":[{"id":"D003521","term":"Cyclopropanes"},{"id":"D003516","term":"Cycloparaffins"},{"id":"D006840","term":"Hydrocarbons, Alicyclic"},{"id":"D006844","term":"Hydrocarbons, Cyclic"},{"id":"D006838","term":"Hydrocarbons"},{"id":"D009930","term":"Organic Chemicals"}]}},"hasResults":true}