{"protocolSection":{"identificationModule":{"nctId":"NCT01014585","orgStudyIdInfo":{"id":"MLN-MD-27"},"organization":{"fullName":"Forest Laboratories","class":"INDUSTRY"},"briefTitle":"Discontinuation Study of the Durability of Effect of Milnacipran for the Treatment of Fibromyalgia","officialTitle":"A Multicenter, Randomized, Double-blind, Placebo-Controlled Discontinuation Study of the Durability of Effect of Milnacipran for the Treatment of Fibromyalgia in Patients Receiving Long-term Milnacipran Treatment"},"statusModule":{"statusVerifiedDate":"2011-09","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2009-11"},"primaryCompletionDateStruct":{"date":"2010-05","type":"ACTUAL"},"studyFirstSubmitDate":"2009-11-13","studyFirstSubmitQcDate":"2009-11-16","studyFirstPostDateStruct":{"date":"2009-11-17","type":"ESTIMATED"},"resultsFirstSubmitDate":"2011-06-07","resultsFirstSubmitQcDate":"2011-09-02","resultsFirstPostDateStruct":{"date":"2011-09-07","type":"ESTIMATED"},"lastUpdateSubmitDate":"2011-09-02","lastUpdatePostDateStruct":{"date":"2011-09-07","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 purpose of this study is to evaluate the durability of effect of milnacipran for the treatment of fibromyalgia in patients receiving long-term milnacipran treatment and to characterize the effects of milnacipran on multiple symptoms of fibromyalgia, as demonstrated by changes in symptoms following the discontinuation of milnacipran."},"conditionsModule":{"conditions":["Fibromyalgia"],"keywords":["Milnacipran","Pain","Durability of Effect","Loss of Therapeutic Response","Fatigue","Forest Research Institute","Savella ®"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":340,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"1","type":"PLACEBO_COMPARATOR","description":"Placebo tablets administered orally twice daily","interventionNames":["Drug: Placebo"]},{"label":"2","type":"EXPERIMENTAL","description":"Milnacipran tablets administered orally twice daily","interventionNames":["Drug: Milnacipran"]}],"interventions":[{"type":"DRUG","name":"Placebo","description":"Placebo tablets administered orally twice daily","armGroupLabels":["1"]},{"type":"DRUG","name":"Milnacipran","description":"Milnacipran tablets administered orally twice daily","armGroupLabels":["2"],"otherNames":["Savella ®"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Time to Loss of Therapeutic Response (LTR)","description":"Time to loss of therapeutic response is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a \\< 30% reduction in Visual Analog Scale (VAS) pain score from pre-milnacipran exposure OR a worsening of fibromyalgia requiring, in the judgment of the investigator, an alternative treatment","timeFrame":"From baseline Visit 3 (week 5) to Visit 7 (week 17)"}],"secondaryOutcomes":[{"measure":"Time to Worsening in Patient Global Impression of Change (PGIC)","description":"Time to worsening in Patient Global Impression of Change is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a PGIC score of 6 or 7. The PGIC is an efficacy assessment on a scale of 1-7 taken at visits 4, 5, 6 and 7. The wording of the assessment is as follows: \"Since the start of the study, overall my fibromyalgia is:\" 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No Change, 5=Minimally Worse, 6=Much Worse, and 7=Very Much Worse.","timeFrame":"From baseline Visit 3 (week 5) to Visit 7 (week 17)"},{"measure":"Time to Worsening in Multidimensional Assessment of Fatigue (MAF)","description":"Time to worsening in MAF is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a 10-point increase from baseline in the global index of fatigue in MAF. Scores range from 1 (no fatigue) to 50 (severe fatigue). The MAF contains 16 items measuring 4 dimensions of fatigue: severity, distress, degree of interference in activities of daily living, and timing. Fourteen of the items contain numerical rating scales (increasing in severity); the remaining 2 items have multiple-choice responses (decreasing in severity).","timeFrame":"From baseline Visit 3 (week 5) to Visit 7 (week 17)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Currently participating in Study MLN-MD-06\n* Receiving a stable dosage of milnacipran (50-200 mg/d) at Screening/Enrollment (Visit 1)\n\nExclusion Criteria:\n\n* Significant risk of suicide\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 12 months\n* Mean systolic blood pressure \\> 180 mm Hg or mean diastolic blood pressure \\> 110 mm Hg at Screening (Visit 1)\n* Active liver disease\n* Severe renal impairment\n* Platelet and bleeding disorders\n* Female patients who are pregnant or breastfeeding","healthyVolunteers":false,"sex":"ALL","stdAges":["CHILD","ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Joel Trugman, MD","affiliation":"Forest Research Institute Inc., A Subsidiary of Forest Laboratories Inc","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Forest Investigative Site 062","city":"Birmingham","state":"Alabama","zip":"35205","country":"United States","geoPoint":{"lat":33.52066,"lon":-86.80249}},{"facility":"Forest Investigative Site 065","city":"Birmingham","state":"Alabama","zip":"35209","country":"United States","geoPoint":{"lat":33.52066,"lon":-86.80249}},{"facility":"Forest Investigative Site 012","city":"Tucson","state":"Arizona","zip":"85704","country":"United States","geoPoint":{"lat":32.22174,"lon":-110.92648}},{"facility":"Forest Investigative Site 007","city":"Fresno","state":"California","zip":"93710","country":"United States","geoPoint":{"lat":36.74773,"lon":-119.77237}},{"facility":"Forest Investigative Site 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010","city":"Eugene","state":"Oregon","zip":"97404","country":"United States","geoPoint":{"lat":44.05207,"lon":-123.08675}},{"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 052","city":"Medford","state":"Oregon","zip":"97504","country":"United States","geoPoint":{"lat":42.32652,"lon":-122.87559}},{"facility":"Forest Investigative Site 041","city":"Portland","state":"Oregon","zip":"97205","country":"United States","geoPoint":{"lat":45.52345,"lon":-122.67621}},{"facility":"Forest Investigative Site 051","city":"Duncansville","state":"Pennsylvania","zip":"16635","country":"United States","geoPoint":{"lat":40.42341,"lon":-78.4339}},{"facility":"Forest Investigative Site 046","city":"Mechanicsburg","state":"Pennsylvania","zip":"17055","country":"United States","geoPoint":{"lat":40.21426,"lon":-77.00859}},{"facility":"Forest Investigative Site 028","city":"Anderson","state":"South Carolina","zip":"29621","country":"United States","geoPoint":{"lat":34.50344,"lon":-82.65013}},{"facility":"Forest Investigative Site 021","city":"Greer","state":"South Carolina","zip":"29651","country":"United States","geoPoint":{"lat":34.93873,"lon":-82.22706}},{"facility":"Forest Investigative Site 006","city":"Salt Lake City","state":"Utah","zip":"84102","country":"United States","geoPoint":{"lat":40.76078,"lon":-111.89105}},{"facility":"Forest Investigative Site 015","city":"Chesapeake","state":"Virginia","zip":"23320","country":"United States","geoPoint":{"lat":36.81904,"lon":-76.27494}},{"facility":"Forest Investigative Site 047","city":"Seattle","state":"Washington","zip":"98104","country":"United States","geoPoint":{"lat":47.60621,"lon":-122.33207}},{"facility":"Forest Investigative Site 036","city":"Wenatchee","state":"Washington","zip":"98801","country":"United States","geoPoint":{"lat":47.42346,"lon":-120.31035}},{"facility":"Forest Investigative Site 063","city":"Racine","state":"Wisconsin","zip":"53406","country":"United States","geoPoint":{"lat":42.72613,"lon":-87.78285}}]},"referencesModule":{"references":[{"pmid":"23953493","type":"DERIVED","citation":"Clauw DJ, Mease PJ, Palmer RH, Trugman JM, Wang Y. Continuing efficacy of milnacipran following long-term treatment in fibromyalgia: a randomized trial. Arthritis Res Ther. 2013 Aug 16;15(4):R88. doi: 10.1186/ar4268."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Upon completion of a long term milnacipran open label study MLN-MD-06, patients were enrolled in the current study MLN-MD-27 (NCT01014585), and received open label treatment with milnacipran for four weeks prior to randomization.","recruitmentDetails":"Recruitment period was from November 2009 through February 2010 at 58 centers in the United States with the last patient visit occurring on June 7, 2010.","groups":[{"id":"FG000","title":"Responders: Placebo (Milnacipran Withdrawn)","description":"The Randomized Population for Responders"},{"id":"FG001","title":"Responders: Milnacipran (Milnacipran Continued)","description":"The Randomized Population for Responders"},{"id":"FG002","title":"Non-Responders: Placebo (Milnacipran Withdrawn)","description":"The Randomized Population for Non-Responders"},{"id":"FG003","title":"Non-Responders: Milnacipran (Milnacipran Continued)","description":"The Randomized Population for Non-Responders"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"51"},{"groupId":"FG001","numSubjects":"100"},{"groupId":"FG002","numSubjects":"60"},{"groupId":"FG003","numSubjects":"129"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"31"},{"groupId":"FG001","numSubjects":"75"},{"groupId":"FG002","numSubjects":"37"},{"groupId":"FG003","numSubjects":"99"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"25"},{"groupId":"FG002","numSubjects":"23"},{"groupId":"FG003","numSubjects":"30"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"3"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"3"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"2"}]},{"type":"Withdrawn Due to Worsening Fibromyalgia","reasons":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"23"},{"groupId":"FG002","numSubjects":"22"},{"groupId":"FG003","numSubjects":"22"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Responders: Placebo (Milnacipran Withdrawn)","description":"Safety Population for Responders: placebo treatment assignment\n\nOne patient in the randomized population for responders assigned to placebo did not take at least one dose of double blind investigational product and therefore was not included in the Safety Population."},{"id":"BG001","title":"Responders: Milnacipran (Milnacipran Continued)","description":"Safety Population for Responders: milnacipran treatment assignment"},{"id":"BG002","title":"Non-Responders: Placebo (Milnacipran Withdrawn)","description":"Safety Population for Non-Responders: placebo treatment assignment"},{"id":"BG003","title":"Non-Responders: Milnacipran (Milnacipran Continued)","description":"Safety Population for Non-Responders: milnacipran treatment assignment\n\nOne patient in the randomized population for non-responders assigned to milnacipran did not take at least one dose of double-blind investigational product and therefore was not included in the Safety population."},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"50"},{"groupId":"BG001","value":"100"},{"groupId":"BG002","value":"60"},{"groupId":"BG003","value":"128"},{"groupId":"BG004","value":"338"}]}],"measures":[{"title":"Age Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"54.0","spread":"8.3"},{"groupId":"BG001","value":"54.5","spread":"9.3"},{"groupId":"BG002","value":"54.7","spread":"9.6"},{"groupId":"BG003","value":"54.8","spread":"9.4"},{"groupId":"BG004","value":"54.6","spread":"9.2"}]}]}]},{"title":"Age, Customized","paramType":"NUMBER","unitOfMeasure":"Years","classes":[{"title":"Between 20 and 60 years","categories":[{"measurements":[{"groupId":"BG000","value":"39"},{"groupId":"BG001","value":"73"},{"groupId":"BG002","value":"38"},{"groupId":"BG003","value":"86"},{"groupId":"BG004","value":"236"}]}]},{"title":">=60 years","categories":[{"measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"27"},{"groupId":"BG002","value":"22"},{"groupId":"BG003","value":"42"},{"groupId":"BG004","value":"102"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"48"},{"groupId":"BG001","value":"96"},{"groupId":"BG002","value":"59"},{"groupId":"BG003","value":"122"},{"groupId":"BG004","value":"325"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"6"},{"groupId":"BG004","value":"13"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"50"},{"groupId":"BG001","value":"100"},{"groupId":"BG002","value":"60"},{"groupId":"BG003","value":"128"},{"groupId":"BG004","value":"338"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Time to Loss of Therapeutic Response (LTR)","description":"Time to loss of therapeutic response is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a \\< 30% reduction in Visual Analog Scale (VAS) pain score from pre-milnacipran exposure OR a worsening of fibromyalgia requiring, in the judgment of the investigator, an alternative treatment","populationDescription":"The Intent to Treat (ITT) Population for Responders is defined as all patients in the Safety Population for Responders with at least 1 post-baseline assessment of primary efficacy parameter. All patients in the Safety Population were included in the ITT population. No efficacy statistical analyses were performed for the Non-Responder population.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"Days","timeFrame":"From baseline Visit 3 (week 5) to Visit 7 (week 17)","groups":[{"id":"OG000","title":"Responders: Placebo (Milnacipran Withdrawn)","description":"Intent to Treat (ITT) Population for Responders: placebo treatment assignment, matching placebo administered orally twice per day."},{"id":"OG001","title":"Responders: Milnacipran (Milnacipran Continued)","description":"Intent to Treat (ITT) Population for Responders: milnacipran treatment assignment, milnacipran 50-200 mg per day, administered orally twice per day."},{"id":"OG002","title":"Non-Responders: Placebo (Milnacipran Withdrawn)","description":"Intent to Treat (ITT) Population for Non-Responders: placebo treatment assignment, matching placebo, administered orally twice per day."},{"id":"OG003","title":"Non-Responders: Milnacipran (Milnacipran Continued)","description":"Intent to Treat (ITT) Population for Non-Responders: milnacipran treatment assignment, 50-200 mg per day, administered orally twice per day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"100"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"56","lowerLimit":"28","upperLimit":"85"},{"groupId":"OG001","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"NA represents not estimable. Not enough participants experienced a loss of therapeutic response to calculate the median value and 95 percent confidence interval."}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0004","statisticalMethod":"Log Rank","paramType":"Hazard Ratio (HR)","paramValue":"0.44","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.27","ciUpperLimit":"0.71"},{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"Days until LTR at the 25th percentile","paramValue":"18","ciPctValue":"95"},{"groupIds":["OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"Days until LTR at the 25th percentile","paramValue":"45","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Time to Worsening in Patient Global Impression of Change (PGIC)","description":"Time to worsening in Patient Global Impression of Change is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a PGIC score of 6 or 7. The PGIC is an efficacy assessment on a scale of 1-7 taken at visits 4, 5, 6 and 7. The wording of the assessment is as follows: \"Since the start of the study, overall my fibromyalgia is:\" 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No Change, 5=Minimally Worse, 6=Much Worse, and 7=Very Much Worse.","populationDescription":"The Intent to Treat (ITT) Population for Responders is defined as all patients in the Safety Population for Responders with at least 1 post-baseline assessment of primary efficacy parameter. All patients in the Safety Population were included in the ITT population. No efficacy statistical analyses were performed for the Non-Responder population.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"Days","timeFrame":"From baseline Visit 3 (week 5) to Visit 7 (week 17)","groups":[{"id":"OG000","title":"Responders: Placebo (Milnacipran Withdrawn)","description":"Intent to Treat (ITT) Population for Responders: placebo treatment assignment, matching placebo administered orally twice per day."},{"id":"OG001","title":"Responders: Milnacipran (Milnacipran Continued)","description":"Intent to Treat (ITT) Population for Responders: milnacipran treatment assignment, milnacipran 50-200 mg per day, administered orally twice per day."},{"id":"OG002","title":"Non-Responders: Placebo (Milnacipran Withdrawn)","description":"Intent to Treat (ITT) Population for Non-Responders: placebo treatment assignment, matching placebo, administered orally twice per day."},{"id":"OG003","title":"Non-Responders: Milnacipran (Milnacipran Continued)","description":"Intent to Treat (ITT) Population for Non-Responders: milnacipran treatment assignment, 50-200 mg per day, administered orally twice per day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"100"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"86","lowerLimit":"30","upperLimit":"NA","comment":"NA represents not estimable. Not enough participants experienced a worsening in PGIC to calculate the upper bound of 95 percent confidence interval."},{"groupId":"OG001","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"NA represents not estimable. Not enough participants experienced a worsening in PGIC to calculate the median value and the 95 percent confidence interval."}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0002","statisticalMethod":"Log Rank","paramType":"Hazard Ratio (HR)","paramValue":"0.36","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.20","ciUpperLimit":"0.63"},{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"Days until LTR at the 25th percentile","paramValue":"22","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Time to Worsening in Multidimensional Assessment of Fatigue (MAF)","description":"Time to worsening in MAF is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a 10-point increase from baseline in the global index of fatigue in MAF. Scores range from 1 (no fatigue) to 50 (severe fatigue). The MAF contains 16 items measuring 4 dimensions of fatigue: severity, distress, degree of interference in activities of daily living, and timing. Fourteen of the items contain numerical rating scales (increasing in severity); the remaining 2 items have multiple-choice responses (decreasing in severity).","populationDescription":"The Intent to Treat (ITT) Population for Responders is defined as all patients in the Safety Population for Responders with at least 1 post-baseline assessment of primary efficacy parameter. All patients in the Safety Population were included in the ITT population. No efficacy statistical analyses were performed for the Non-Responder population.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"Days","timeFrame":"From baseline Visit 3 (week 5) to Visit 7 (week 17)","groups":[{"id":"OG000","title":"Responders: Placebo (Milnacipran Withdrawn)","description":"Intent to Treat (ITT) Population for Responders: placebo treatment assignment, matching placebo administered orally twice per day."},{"id":"OG001","title":"Responders: Milnacipran (Milnacipran Continued)","description":"Intent to Treat (ITT) Population for Responders: milnacipran treatment assignment, milnacipran 50-200 mg per day, administered orally twice per day."},{"id":"OG002","title":"Non-Responders: Placebo (Milnacipran Withdrawn)","description":"Intent to Treat (ITT) Population for Non-Responders: placebo treatment assignment, matching placebo, administered orally twice per day."},{"id":"OG003","title":"Non-Responders: Milnacipran (Milnacipran Continued)","description":"Intent to Treat (ITT) Population for Non-Responders: milnacipran treatment assignment, 50-200 mg per day, administered orally twice per day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"100"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"NA represents not estimable. Not enough participants experienced a worsening in the MAF to calculate the median value and the 95 percent confidence interval."},{"groupId":"OG001","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"NA represents not estimable. Not enough participants experienced a worsening in the MAF to calculate the median value and the 95 percent confidence interval."}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.4104","statisticalMethod":"Log Rank","paramType":"Hazard Ratio (HR)","paramValue":"0.80","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.46","ciUpperLimit":"1.38"},{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"Days until LTR at the 25th percentile","paramValue":"18","ciPctValue":"95"},{"groupIds":["OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"Days until LTR at the 25th percentile","paramValue":"30","ciPctValue":"95"}]}]},"adverseEventsModule":{"frequencyThreshold":"5","eventGroups":[{"id":"EG000","title":"Responders: Placebo (Milnacipran Withdrawn)","description":"Safety Population for Responders: placebo 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population for non-responders assigned to milnacipran did not take at least one dose of double blind investigational product and therefore was not included in the Safety population.","seriousNumAffected":3,"seriousNumAtRisk":128,"otherNumAffected":30,"otherNumAtRisk":128}],"seriousEvents":[{"term":"Non-cardiac chest pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":50},{"groupId":"EG001","numAffected":1,"numAtRisk":100},{"groupId":"EG002","numAffected":0,"numAtRisk":60},{"groupId":"EG003","numAffected":0,"numAtRisk":128}]},{"term":"Bradycardia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 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13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":50},{"groupId":"EG001","numAffected":0,"numAtRisk":100},{"groupId":"EG002","numAffected":0,"numAtRisk":60},{"groupId":"EG003","numAffected":1,"numAtRisk":128}]},{"term":"Osteoarthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":50},{"groupId":"EG001","numAffected":0,"numAtRisk":100},{"groupId":"EG002","numAffected":1,"numAtRisk":60},{"groupId":"EG003","numAffected":0,"numAtRisk":128}]}],"otherEvents":[{"term":"Sinusitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 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13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":50},{"groupId":"EG001","numAffected":0,"numAtRisk":100},{"groupId":"EG002","numAffected":0,"numAtRisk":60},{"groupId":"EG003","numAffected":0,"numAtRisk":128}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":50},{"groupId":"EG001","numAffected":4,"numAtRisk":100},{"groupId":"EG002","numAffected":1,"numAtRisk":60},{"groupId":"EG003","numAffected":9,"numAtRisk":128}]},{"term":"Upper respiratory tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":50},{"groupId":"EG001","numAffected":4,"numAtRisk":100},{"groupId":"EG002","numAffected":1,"numAtRisk":60},{"groupId":"EG003","numAffected":7,"numAtRisk":128}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":50},{"groupId":"EG001","numAffected":4,"numAtRisk":100},{"groupId":"EG002","numAffected":3,"numAtRisk":60},{"groupId":"EG003","numAffected":4,"numAtRisk":128}]},{"term":"Fibromyalgia","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":50},{"groupId":"EG001","numAffected":3,"numAtRisk":100},{"groupId":"EG002","numAffected":3,"numAtRisk":60},{"groupId":"EG003","numAffected":3,"numAtRisk":128}]},{"term":"Bronchitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":50},{"groupId":"EG001","numAffected":2,"numAtRisk":100},{"groupId":"EG002","numAffected":3,"numAtRisk":60},{"groupId":"EG003","numAffected":2,"numAtRisk":128}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":50},{"groupId":"EG001","numAffected":2,"numAtRisk":100},{"groupId":"EG002","numAffected":3,"numAtRisk":60},{"groupId":"EG003","numAffected":2,"numAtRisk":128}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"OTHER","restrictiveAgreement":true,"otherDetails":"All data generated in this study is the property of Forest Research Institute, Inc. An integrated clinical and statistical report was 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":"Joel Trugman, MD","organization":"Forest Research Institute, Inc., a subsidiary of Forest Laboratories, Inc.","email":"joel.trugman@frx.com","phone":"201-427-8681"}}},"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}