drugset / Trial / NCT01234675

The Effects of Milnacipran on Sleep Disturbance in Fibromyalgia

NCT01234675

Phase 4 Completed 19 enrolled Mansoor Ahmed M.D. Forest Laboratories · collab
RandomizedCrossoverDouble-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Milnacipran Other / unclassified 50 mg