{"protocolSection":{"identificationModule":{"nctId":"NCT01077375","orgStudyIdInfo":{"id":"MLN-MD-28"},"organization":{"fullName":"Forest Laboratories","class":"INDUSTRY"},"briefTitle":"Study of Milnacipran in Patients With Inadequate Response to Duloxetine for the Treatment of Fibromyalgia","officialTitle":"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Switch Study to Evaluate the Safety, Tolerability and Efficacy of Milnacipran in Patients With an Inadequate Response to Duloxetine for the Treatment of Fibromyalgia"},"statusModule":{"statusVerifiedDate":"2011-12","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2010-02"},"primaryCompletionDateStruct":{"date":"2010-12","type":"ACTUAL"},"completionDateStruct":{"date":"2011-01","type":"ACTUAL"},"studyFirstSubmitDate":"2010-02-25","studyFirstSubmitQcDate":"2010-02-25","studyFirstPostDateStruct":{"date":"2010-03-01","type":"ESTIMATED"},"resultsFirstSubmitDate":"2011-12-21","resultsFirstSubmitQcDate":"2011-12-21","resultsFirstPostDateStruct":{"date":"2012-01-26","type":"ESTIMATED"},"lastUpdateSubmitDate":"2011-12-21","lastUpdatePostDateStruct":{"date":"2012-01-26","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Forest Laboratories","class":"INDUSTRY"},"collaborators":[{"name":"Cypress Bioscience, Inc.","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The objective of this study is to evaluate the safety, tolerability and efficacy of milnacipran in patients with an inadequate response to duloxetine for the treatment of fibromyalgia.","detailedDescription":"* Two weeks Duloxetine 60 mg Open-Label Period\n* Randomization to Double-Blind Treatment Period: 10 weeks Milnacipran (direct switch) or 10 weeks placebo (one week blinded 30 mg duloxetine)\n* One week Double-Blind Down-Taper Period"},"conditionsModule":{"conditions":["Fibromyalgia"],"keywords":["Milnacipran","Duloxetine","Switch","Forest Research Institute"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":107,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Placebo tablets, twice a day, oral administration","interventionNames":["Drug: Placebo"]},{"label":"Milnacipran","type":"EXPERIMENTAL","description":"Milnacipran tablets, 100 to 200 mg/day, oral administration, twice daily in divided doses.","interventionNames":["Drug: Milnacipran"]}],"interventions":[{"type":"DRUG","name":"Placebo","description":"* Placebo tablets, oral administration, twice daily for 10 weeks during randomized, double-blind treatment period. Duloxetine capsules, oral administration, 30 mg/day for 1 week after randomization to effect a duloxetine down-taper.\n* Placebo tablets, twice daily for 1 week during double-blind down-taper treatment period.","armGroupLabels":["Placebo"]},{"type":"DRUG","name":"Milnacipran","description":"* Milnacipran tablets, 100 to 200 mg/day, oral administration, twice daily in divided doses for 10 weeks during randomized, double-blind treatment period. Placebo capsules, 1 capsule/day administered for 1 week after randomization to maintain double-blind duloxetine down-taper.\n* Milnacipran tablets, 100 to 0 mg/day, oral administration, twice daily in divided doses for 1 week during double-blind down-taper treatment period.","armGroupLabels":["Milnacipran"],"otherNames":["Savella"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Responder Status Based on Patient Global Impression of Change (PGIC) Score at Visit 5 (Week 13)","description":"The PGIC is a patient-reported measure of improvement in pain sensation and quality of life scored on a scale from 1 (very much improved) to 7 (very much worse). To meet the criteria for a responder in this study, patients must report a score of 1 (very much improved) or 2 (much improved) on the PGIC.","timeFrame":"Assessed at Visit 4 (Week 9) and Visit 5 (Week 13) or early termination. Presented results generated via LOCF approach."}],"secondaryOutcomes":[{"measure":"Change From Baseline to Visit 5 (Week 13) in the Visual Analog Scale (VAS) 1-week Pain Recall Score","description":"The VAS assessment ranges from a scale of 0 (no pain) to 100 (worst possible pain).","timeFrame":"Change from Baseline (Week 3) to Visit 5 (Week 13)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Diagnosis of fibromyalgia\n* Have been treated with a stable dosage of duloxetine (60 mg/day) for ≥ 4 weeks immediately before Screening (Visit 1)\n* Duloxetine must have been prescribed for the treatment of Fibromyalgia\n* Have a VAS 1-week pain recall score ≥ 40 mm and ≤ 90 mm\n* At Visit 2, to be eligible to enter the randomized treatment period, must continue to have a VAS 1-week pain recall score ≥ 40 mm and be dissatisfied with current Duloxetine treatment.\n\nExclusion Criteria:\n\n* Suicidal risk\n* History of mania, bipolar disorder, psychotic disorder, schizophrenia, or a current episode of major depressive disorder\n* Myocardial infarction and/or stroke within the prior 6 months\n* Systolic blood pressure \\> 160 mm Hg or mean diastolic blood pressure \\> 100 mm Hg at Screening (Visit 1)\n* Substance abuse\n* Pulmonary dysfunction\n* Severe renal impairment\n* Active cardiac disease\n* Liver disease\n* Uncontrolled narrow-angle glaucoma\n* Autoimmune disease\n* Cancer\n* Inflammatory bowel disease\n* Unstable endocrine disease\n* Prostatic enlargement\n* Female patients who are pregnant or breastfeeding","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"70 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Allan Spera","affiliation":"Forest Research Institute Inc., A Subsidiary of Forest Laboratories","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Forest Investigative Site 013","city":"Sacramento","state":"California","zip":"95825","country":"United States","geoPoint":{"lat":38.58157,"lon":-121.4944}},{"facility":"Forest Investigative Site 022","city":"Cromwell","state":"Connecticut","zip":"06416","country":"United States","geoPoint":{"lat":41.5951,"lon":-72.64537}},{"facility":"Forest Investigative Site 021","city":"Danbury","state":"Connecticut","zip":"06810","country":"United States","geoPoint":{"lat":41.39482,"lon":-73.45401}},{"facility":"Forest Investigative Site 007","city":"Delray Beach","state":"Florida","zip":"33484","country":"United States","geoPoint":{"lat":26.46146,"lon":-80.07282}},{"facility":"Forest Investigative Site 008","city":"Ocala","state":"Florida","zip":"34471","country":"United States","geoPoint":{"lat":29.1872,"lon":-82.14009}},{"facility":"Forest Investigative Site 009","city":"Orlando","state":"Florida","zip":"32806","country":"United States","geoPoint":{"lat":28.53834,"lon":-81.37924}},{"facility":"Forest Investigative Site 016","city":"Orlando","state":"Florida","zip":"32806","country":"United States","geoPoint":{"lat":28.53834,"lon":-81.37924}},{"facility":"Forest Investigative Site 012","city":"St. Petersburg","state":"Florida","zip":"33709","country":"United States","geoPoint":{"lat":27.77086,"lon":-82.67927}},{"facility":"Forest Investigative Site 019","city":"Tampa","state":"Florida","zip":"33614","country":"United States","geoPoint":{"lat":27.94752,"lon":-82.45843}},{"facility":"Forest Investigative Site 006","city":"Atlanta","state":"Georgia","zip":"30328","country":"United States","geoPoint":{"lat":33.749,"lon":-84.38798}},{"facility":"Forest Investigative Site 024","city":"Atlanta","state":"Georgia","zip":"30328","country":"United States","geoPoint":{"lat":33.749,"lon":-84.38798}},{"facility":"Forest Investigative Site 015","city":"Evansville","state":"Indiana","zip":"47713","country":"United States","geoPoint":{"lat":37.97476,"lon":-87.55585}},{"facility":"Forest Investigative Site 005","city":"Worchester","state":"Massachusetts","zip":"01610","country":"United States"},{"facility":"Forest Investigative Site 010","city":"Jackson","state":"Mississippi","zip":"39202","country":"United States","geoPoint":{"lat":32.29876,"lon":-90.18481}},{"facility":"Forest Investigative Site 025","city":"St Louis","state":"Missouri","zip":"63141","country":"United States","geoPoint":{"lat":38.62727,"lon":-90.19789}},{"facility":"Forest Investigative Site 018","city":"Willingboro","state":"New Jersey","zip":"08046","country":"United States","geoPoint":{"lat":40.02789,"lon":-74.86905}},{"facility":"Forest Investigative Site 014","city":"Syracuse","state":"New York","zip":"13210","country":"United States","geoPoint":{"lat":43.04812,"lon":-76.14742}},{"facility":"Forest Investigative Site 023","city":"Charlotte","state":"North Carolina","zip":"28209","country":"United States","geoPoint":{"lat":35.22709,"lon":-80.84313}},{"facility":"Forest Investigative Site 002","city":"Cincinnati","state":"Ohio","zip":"45219","country":"United States","geoPoint":{"lat":39.12711,"lon":-84.51439}},{"facility":"Forest Investigative Site 003","city":"Cleveland","state":"Ohio","zip":"44122","country":"United States","geoPoint":{"lat":41.4995,"lon":-81.69541}},{"facility":"Forest Investigative Site 001","city":"Medford","state":"Oregon","zip":"97504","country":"United States","geoPoint":{"lat":42.32652,"lon":-122.87559}},{"facility":"Forest Investigative Site 020","city":"Mechanicsburg","state":"Pennsylvania","zip":"17055","country":"United States","geoPoint":{"lat":40.21426,"lon":-77.00859}},{"facility":"Forest Investigative Site 011","city":"Greer","state":"South Carolina","zip":"29651","country":"United States","geoPoint":{"lat":34.93873,"lon":-82.22706}},{"facility":"Forest Investigative Site 004","city":"Salt Lake City","state":"Utah","zip":"84102","country":"United States","geoPoint":{"lat":40.76078,"lon":-111.89105}},{"facility":"Forest Investigative Site 017","city":"Bellevue","state":"Washington","zip":"98007","country":"United States","geoPoint":{"lat":47.61038,"lon":-122.20068}},{"facility":"Forest Investigative Site 026","city":"Racine","state":"Wisconsin","zip":"53406","country":"United States","geoPoint":{"lat":42.72613,"lon":-87.78285}}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"All participants were given an open-label treatment of duloxetine 60 mg once daily for a two week period before randomization.\n\nPatients randomized to placebo received 1 week of duloxetine 30 mg to effect a duloxetine down-taper. Patients randomized to milnacipran received 1 week of placebo capsules to maintain the blind.","recruitmentDetails":"Recruitment occurred over an 8 month period from February 2010 to September 2010 at 25 study centers in the United States. Last patient last visit occurred on December 22nd, 2010.","groups":[{"id":"FG000","title":"Placebo","description":"Randomized Population: placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration."},{"id":"FG001","title":"Milnacipran","description":"Randomized Population: milnacipran treatment assignment, 100 to 200 mg/day, twice a day in divided doses, oral administration."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","comment":"One randomized patient not taking study drug was excluded from the Double-blind Safety Population.","numSubjects":"86"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"51"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"35"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"15"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"8"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"6"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"5"}]},{"type":"Other Reason","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Placebo","description":"Double-blind Safety Population: Placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration."},{"id":"BG001","title":"Milnacipran","description":"Double-blind Safety Population: milnacipran treatment assignment, 100 to 200 md/day, twice a day in divided doses, oral administration.\n\nOne patient randomized to the milnacipran treatment group did not take at least one dose of double-blind study drug and was therefore not included in the Double-blind Safety Population."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"21"},{"groupId":"BG001","value":"85"},{"groupId":"BG002","value":"106"}]}],"measures":[{"title":"Age Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"48.5","spread":"11.3"},{"groupId":"BG001","value":"48.5","spread":"10.5"},{"groupId":"BG002","value":"48.5","spread":"10.6"}]}]}]},{"title":"Age, Customized","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"18 to 59","categories":[{"measurements":[{"groupId":"BG000","value":"17"},{"groupId":"BG001","value":"77"},{"groupId":"BG002","value":"94"}]}]},{"title":"60 to 70","categories":[{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"12"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"19"},{"groupId":"BG001","value":"79"},{"groupId":"BG002","value":"98"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"8"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"21"},{"groupId":"BG001","value":"85"},{"groupId":"BG002","value":"106"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Responder Status Based on Patient Global Impression of Change (PGIC) Score at Visit 5 (Week 13)","description":"The PGIC is a patient-reported measure of improvement in pain sensation and quality of life scored on a scale from 1 (very much improved) to 7 (very much worse). To meet the criteria for a responder in this study, patients must report a score of 1 (very much improved) or 2 (much improved) on the PGIC.","populationDescription":"ITT Population: patients in the Double-blind Safety Population with ≥ 1 PGIC post-baseline assessment. Double-blind Safety Population includes 6 patients who were not included in ITT population. Presented results generated via LOCF approach. No statistical comparisons between groups are presented; study was exploratory, not hypothesis-testing.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Assessed at Visit 4 (Week 9) and Visit 5 (Week 13) or early termination. Presented results generated via LOCF approach.","groups":[{"id":"OG000","title":"Placebo","description":"Intent-to-treat (ITT) Population, placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration."},{"id":"OG001","title":"Milnacipran","description":"Intent-to-treat Population, milnacipran treatment assignment, 100 to 200 mg/day, twice a day, oral administration.\n\nFlexible dosing from 50 mg/day to 200 mg/day was allowed except at a) the initial dosage after randomization had to be 100 mg/day, b) the dose range during week 1 of the randomized double-blind treatment period was 50 to 100 mg/day, and c) patients had to be on at least 100 mg/day at Visit 3 (Week 5)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"79"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"26"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to Visit 5 (Week 13) in the Visual Analog Scale (VAS) 1-week Pain Recall Score","description":"The VAS assessment ranges from a scale of 0 (no pain) to 100 (worst possible pain).","populationDescription":"ITT Population: patients in the Double-blind Safety Population with ≥ 1 PGIC post-baseline assessment. Double-blind Safety Population includes 6 patients who were not included in ITT population. Presented results generated via LOCF approach. No statistical comparisons between groups are presented; study was exploratory, not hypothesis-testing.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on a scale","timeFrame":"Change from Baseline (Week 3) to Visit 5 (Week 13)","groups":[{"id":"OG000","title":"Placebo","description":"Intent-to-treat Population, placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration."},{"id":"OG001","title":"Milnacipran","description":"Intent-to-treat Population, milnacipran treatment assignment, 100 to 200 mg/day, twice a day, oral administration.\n\nFlexible dosing from 50 mg/day to 200 mg/day was allowed except at a) the initial dosage after randomization had to be 100 mg/day, b) the dose range during week 1 of the randomized double-blind treatment period was 50 to 100 mg/day, and c) patients had to be on at least 100 mg/day at Visit 3 (Week 5)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"79"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.3","spread":"22.5"},{"groupId":"OG001","value":"-12.3","spread":"27.3"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Adverse event data was collected over a nearly 10 month period from March 4th, 2010 through December 22, 2010.","eventGroups":[{"id":"EG000","title":"Placebo","description":"Double-blind Safety Population: placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration.","seriousNumAffected":0,"seriousNumAtRisk":21,"otherNumAffected":16,"otherNumAtRisk":21},{"id":"EG001","title":"Milnacipran","description":"Double-blind Safety Population: milnacipran treatment assignment, 100 to 200 mg/day, twice a day, oral administration.\n\nOne patient randomized to the milnacipran treatment group did not take at least one dose of double-blind study drug and was therefore not included in the Double-blind Safety Population.\n\nFlexible dosing from 50 mg/day to 200 mg/day was allowed except at a) the initial dosage after randomization had to be 100 mg/day, b) the dose range during week 1 of the randomized double-blind treatment period was 50 to 100 mg/day, and c) patients had to be on at least 100 mg/day at Visit 3 (Week 5).","seriousNumAffected":2,"seriousNumAtRisk":85,"otherNumAffected":63,"otherNumAtRisk":85}],"seriousEvents":[{"term":"Hypersensitivity","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (13.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21},{"groupId":"EG001","numAffected":1,"numAtRisk":85}]},{"term":"Suicidal ideation","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (13.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21},{"groupId":"EG001","numAffected":1,"numAtRisk":85}]}],"otherEvents":[{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (13.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":21},{"groupId":"EG001","numAffected":18,"numAtRisk":85}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (13.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21},{"groupId":"EG001","numAffected":13,"numAtRisk":85}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (13.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21},{"groupId":"EG001","numAffected":10,"numAtRisk":85}]},{"term":"Insomnia","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (13.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21},{"groupId":"EG001","numAffected":9,"numAtRisk":85}]},{"term":"Hot flush","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (13.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21},{"groupId":"EG001","numAffected":7,"numAtRisk":85}]},{"term":"Irritability","organSystem":"General disorders","sourceVocabulary":"MedDRA (13.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21},{"groupId":"EG001","numAffected":6,"numAtRisk":85}]},{"term":"Nasopharyngitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (13.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21},{"groupId":"EG001","numAffected":6,"numAtRisk":85}]},{"term":"Anxiety","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (13.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21},{"groupId":"EG001","numAffected":5,"numAtRisk":85}]},{"term":"Blood pressure increased","organSystem":"Investigations","sourceVocabulary":"MedDRA (13.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21},{"groupId":"EG001","numAffected":5,"numAtRisk":85}]},{"term":"Hyperhidrosis","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (13.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21},{"groupId":"EG001","numAffected":5,"numAtRisk":85}]},{"term":"Diarrhea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (13.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":21},{"groupId":"EG001","numAffected":4,"numAtRisk":85}]},{"term":"Fatigue","organSystem":"General disorders","sourceVocabulary":"MedDRA (13.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21},{"groupId":"EG001","numAffected":3,"numAtRisk":85}]},{"term":"Migraine","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (13.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21},{"groupId":"EG001","numAffected":1,"numAtRisk":85}]},{"term":"Paresthesia","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (13.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21},{"groupId":"EG001","numAffected":1,"numAtRisk":85}]},{"term":"Muscle spasms","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (13.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21},{"groupId":"EG001","numAffected":0,"numAtRisk":85}]}]},"moreInfoModule":{"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.\n\nPublication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc."},"pointOfContact":{"title":"Allan Spera, Director, Clinical Development","organization":"Forest Research Institute","email":"Allan.Spera@frx.com","phone":"(201) 427-8399"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D005356","term":"Fibromyalgia"}],"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"}]},"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}