Discontinuation Study of the Durability of Effect of Milnacipran for the Treatment of Fibromyalgia
- Registration Number
- NCT01014585
- Lead Sponsor
- Forest Laboratories
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 340
- Currently participating in Study MLN-MD-06
- Receiving a stable dosage of milnacipran (50-200 mg/d) at Screening/Enrollment (Visit 1)
- Significant risk of suicide
- History of mania, bipolar disorder, psychotic disorder, schizophrenia, or a current episode of major depressive disorder
- Myocardial infarction and/or stroke within the prior 12 months
- Mean systolic blood pressure > 180 mm Hg or mean diastolic blood pressure > 110 mm Hg at Screening (Visit 1)
- Active liver disease
- Severe renal impairment
- Platelet and bleeding disorders
- Female patients who are pregnant or breastfeeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Placebo Placebo tablets administered orally twice daily 2 Milnacipran Milnacipran tablets administered orally twice daily
- Primary Outcome Measures
Name Time Method Time to Loss of Therapeutic Response (LTR) From baseline Visit 3 (week 5) to Visit 7 (week 17) 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
- Secondary Outcome Measures
Name Time Method Time to Worsening in Patient Global Impression of Change (PGIC) From baseline Visit 3 (week 5) to Visit 7 (week 17) 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.
Time to Worsening in Multidimensional Assessment of Fatigue (MAF) From baseline Visit 3 (week 5) to Visit 7 (week 17) 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).
Trial Locations
- Locations (58)
Forest Investigative Site 060
🇺🇸Pembroke Pines, Florida, United States
Forest Investigative Site 009
🇺🇸Atlanta, Georgia, United States
Forest Investigative Site 008
🇺🇸Worcester, Massachusetts, United States
Forest Investigative Site 028
🇺🇸Anderson, South Carolina, United States
Forest Investigative Site 026
🇺🇸Honolulu, Hawaii, United States
Forest Investigative Site 047
🇺🇸Seattle, Washington, United States
Forest Investigative Site 025
🇺🇸Sacramento, California, United States
Forest Investigative Site 032
🇺🇸Pismo Beach, California, United States
Forest Investigative Site 056
🇺🇸Libertyville, Illinois, United States
Forest Investigative Site 019
🇺🇸San Diego, California, United States
Forest Investigative Site 039
🇺🇸Vista, California, United States
Forest Investigative Site 013
🇺🇸Ocala, Florida, United States
Forest Investigative Site 007
🇺🇸Fresno, California, United States
Forest Investigative Site 004
🇺🇸St. Louis, Missouri, United States
Forest Investigative Site 015
🇺🇸Chesapeake, Virginia, United States
Forest Investigative Site 050
🇺🇸Cromwell, Connecticut, United States
Forest Investigative Site 064
🇺🇸Frederick, Maryland, United States
Forest Investigative Site 011
🇺🇸Delray Beach, Florida, United States
Forest Investigative Site 035
🇺🇸Great Neck, New York, United States
Forest Investigative Site 048
🇺🇸N. Dartmouth, Massachusetts, United States
Forest Investigative Site 027
🇺🇸Syracuse, New York, United States
Forest Investigative Site 006
🇺🇸Salt Lake City, Utah, United States
Forest Investigative Site 018
🇺🇸Greensboro, North Carolina, United States
Forest Investigative Site 017
🇺🇸Springfield, Massachusetts, United States
Forest Investigative Site 010
🇺🇸Eugene, Oregon, United States
Forest Investigative Site 024
🇺🇸Salisbury, North Carolina, United States
Forest Investigative Site 062
🇺🇸Birmingham, Alabama, United States
Forest Investigative Site 065
🇺🇸Birmingham, Alabama, United States
Forest Investigative Site 038
🇺🇸Peoria, Illinois, United States
Forest Investigative Site 040
🇺🇸Albuquerque, New Mexico, United States
Forest Investigative Site 043
🇺🇸Palm Harbor, Florida, United States
Forest Investigative Site 002
🇺🇸Greenville, North Carolina, United States
Forest Investigative Site 003
🇺🇸Cincinnati, Ohio, United States
Forest Investigative Site 059
🇺🇸Columbus, Ohio, United States
Forest Investigative Site 005
🇺🇸Cleveland, Ohio, United States
Forest Investigative Site 044
🇺🇸Eugene, Oregon, United States
Forest Investigative Site 052
🇺🇸Medford, Oregon, United States
Forest Investigative Site 046
🇺🇸Mechanicsburg, Pennsylvania, United States
Forest Investigative Site 036
🇺🇸Wenatchee, Washington, United States
Forest Investigative Site 041
🇺🇸Portland, Oregon, United States
Forest Investigative Site 066
🇺🇸Atlanta, Georgia, United States
Forest Investigative Site 031
🇺🇸Evansville, Indiana, United States
Forest Investigative Site 049
🇺🇸Danbury, Connecticut, United States
Forest Investigative Site 016
🇺🇸Orlando, Florida, United States
Forest Investigative Site 057
🇺🇸Santa Ana, California, United States
Forest Investigative Site 061
🇺🇸Kalamazoo, Michigan, United States
Forest Investigative Site 030
🇺🇸Newton, Massachusetts, United States
Forest Investigative Site 020
🇺🇸Jackson, Mississippi, United States
Forest Investigative Site 033
🇺🇸Cherry Hill, New Jersey, United States
Forest Investigative Site 001
🇺🇸Medford, Oregon, United States
Forest Investigative Site 042
🇺🇸Winston-Salem, North Carolina, United States
Forest Investigative Site 021
🇺🇸Greer, South Carolina, United States
Forest Investigative Site 051
🇺🇸Duncansville, Pennsylvania, United States
Forest Investigative Site 063
🇺🇸Racine, Wisconsin, United States
Forest Investigative Site 055
🇺🇸Stamford, Connecticut, United States
Forest Investigative Site 012
🇺🇸Tucson, Arizona, United States
Forest Investigative Site 014
🇺🇸Rochester, New York, United States
Forest Investigative Site 054
🇺🇸Charlotte, North Carolina, United States