The Effects of Milnacipran on Sleep Disturbance in Fibromyalgia
Summary
Fibromyalgia is a condition of chronic widespread pain, sleep disturbance and fatigue. Most of the patients with fibromyalgia complain of either non-restorative sleep or complaints of disturbed sleep due to pain. The study aimed at examining the effects of milnacipran on sleep disturbance in patients with fibromyalgia. The study is a randomized, double-blind, placebo controlled, two way crossover polysomnography (PSG) study to explore the effects of milnacipran on sleep disturbance. Patients received either milnacipran 50 mg twice a day (BID) or matching placebo.
Timeline
- Start
- 2010-11
- Primary completion
- 2014-02
- Completion
- 2014-02
Outcome
Missed primary endpoint
paper Subjects treated with milnacipran showed no significant improvements in WASO and NAASO, but showed reduced SE (p = 0.049). PMID 26414990 ↗
registry analysis (superiority test); Milnacipran vs Placebo; p = 0.424; Paired difference 4.6 (95% CI -7.3 to 16.6); Paired T test NCT01234675 ↗
registry analysis (superiority test); Milnacipran; p = 0.049; Paired difference -6.1 (95% CI -12.2 to -0.04); Paired T test NCT01234675 ↗
registry analysis (superiority test); Milnacipran vs Placebo; p = 0.056; Paired difference 22.6 (95% CI -0.6 to 45.8); Paired T test NCT01234675 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Milnacipran | Other / unclassified | 50 mg | — |