Study of Milnacipran in Patients With Inadequate Response to Duloxetine for the Treatment of Fibromyalgia
- Registration Number
- NCT01077375
- Lead Sponsor
- Forest Laboratories
- Brief Summary
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.
- Detailed Description
* Two weeks Duloxetine 60 mg Open-Label Period
* Randomization to Double-Blind Treatment Period: 10 weeks Milnacipran (direct switch) or 10 weeks placebo (one week blinded 30 mg duloxetine)
* One week Double-Blind Down-Taper Period
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 107
- Diagnosis of fibromyalgia
- Have been treated with a stable dosage of duloxetine (60 mg/day) for ≥ 4 weeks immediately before Screening (Visit 1)
- Duloxetine must have been prescribed for the treatment of Fibromyalgia
- Have a VAS 1-week pain recall score ≥ 40 mm and ≤ 90 mm
- 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.
- Suicidal risk
- History of mania, bipolar disorder, psychotic disorder, schizophrenia, or a current episode of major depressive disorder
- Myocardial infarction and/or stroke within the prior 6 months
- Systolic blood pressure > 160 mm Hg or mean diastolic blood pressure > 100 mm Hg at Screening (Visit 1)
- Substance abuse
- Pulmonary dysfunction
- Severe renal impairment
- Active cardiac disease
- Liver disease
- Uncontrolled narrow-angle glaucoma
- Autoimmune disease
- Cancer
- Inflammatory bowel disease
- Unstable endocrine disease
- Prostatic enlargement
- Female patients who are pregnant or breastfeeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo tablets, twice a day, oral administration Milnacipran Milnacipran Milnacipran tablets, 100 to 200 mg/day, oral administration, twice daily in divided doses.
- Primary Outcome Measures
Name Time Method Responder Status Based on Patient Global Impression of Change (PGIC) Score at Visit 5 (Week 13) Assessed at Visit 4 (Week 9) and Visit 5 (Week 13) or early termination. Presented results generated via LOCF approach. 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline to Visit 5 (Week 13) in the Visual Analog Scale (VAS) 1-week Pain Recall Score Change from Baseline (Week 3) to Visit 5 (Week 13) The VAS assessment ranges from a scale of 0 (no pain) to 100 (worst possible pain).
Trial Locations
- Locations (26)
Forest Investigative Site 003
🇺🇸Cleveland, Ohio, United States
Forest Investigative Site 024
🇺🇸Atlanta, Georgia, United States
Forest Investigative Site 010
🇺🇸Jackson, Mississippi, United States
Forest Investigative Site 025
🇺🇸St. Louis, Missouri, United States
Forest Investigative Site 019
🇺🇸Tampa, Florida, United States
Forest Investigative Site 002
🇺🇸Cincinnati, Ohio, United States
Forest Investigative Site 004
🇺🇸Salt Lake City, Utah, United States
Forest Investigative Site 007
🇺🇸Delray Beach, Florida, United States
Forest Investigative Site 008
🇺🇸Ocala, Florida, United States
Forest Investigative Site 022
🇺🇸Cromwell, Connecticut, United States
Forest Investigative Site 013
🇺🇸Sacramento, California, United States
Forest Investigative Site 021
🇺🇸Danbury, Connecticut, United States
Forest Investigative Site 009
🇺🇸Orlando, Florida, United States
Forest Investigative Site 006
🇺🇸Atlanta, Georgia, United States
Forest Investigative Site 018
🇺🇸Willingboro, New Jersey, United States
Forest Investigative Site 014
🇺🇸Syracuse, New York, United States
Forest Investigative Site 015
🇺🇸Evansville, Indiana, United States
Forest Investigative Site 023
🇺🇸Charlotte, North Carolina, United States
Forest Investigative Site 020
🇺🇸Mechanicsburg, Pennsylvania, United States
Forest Investigative Site 026
🇺🇸Racine, Wisconsin, United States
Forest Investigative Site 001
🇺🇸Medford, Oregon, United States
Forest Investigative Site 011
🇺🇸Greer, South Carolina, United States
Forest Investigative Site 012
🇺🇸St. Petersburg, Florida, United States
Forest Investigative Site 016
🇺🇸Orlando, Florida, United States
Forest Investigative Site 005
🇺🇸Worchester, Massachusetts, United States
Forest Investigative Site 017
🇺🇸Bellevue, Washington, United States