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.
* 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
107
* 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. * Placebo tablets, twice daily for 1 week during double-blind down-taper treatment period.
* 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. * Milnacipran tablets, 100 to 0 mg/day, oral administration, twice daily in divided doses for 1 week during double-blind down-taper treatment period.
Responder Status Based on Patient Global Impression of Change (PGIC) Score at Visit 5 (Week 13)
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.
Time frame: Assessed at Visit 4 (Week 9) and Visit 5 (Week 13) or early termination. Presented results generated via LOCF approach.
Change From Baseline to Visit 5 (Week 13) in the Visual Analog Scale (VAS) 1-week Pain Recall Score
The VAS assessment ranges from a scale of 0 (no pain) to 100 (worst possible pain).
Time frame: Change from Baseline (Week 3) to Visit 5 (Week 13)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Forest Investigative Site 013
Sacramento, California, United States
Forest Investigative Site 022
Cromwell, Connecticut, United States
Forest Investigative Site 021
Danbury, Connecticut, United States
Forest Investigative Site 007
Delray Beach, Florida, United States
Forest Investigative Site 008
Ocala, Florida, United States
Forest Investigative Site 009
Orlando, Florida, United States
Forest Investigative Site 016
Orlando, Florida, United States
Forest Investigative Site 012
St. Petersburg, Florida, United States
Forest Investigative Site 019
Tampa, Florida, United States
Forest Investigative Site 006
Atlanta, Georgia, United States
...and 16 more locations