CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 19 enrolled
Drug / intervention
Milnacipran +1 moredrug
Likely dose
Milnacipran 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01234675
NCT01234675Phase 4Completed
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The Effects of Milnacipran on Sleep Disturbance in Fibromyalgia

Mansoor Ahmed M.D.·interventional·Posted Nov 4, 2010·Updated Aug 21, 2019

In Brief

A Phase 4 clinical trial evaluating Milnacipran and Placebo for Sleep Disorders and 2 related conditions. Completed, enrolled 19 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSleep Disorders, Fibromyalgia, Sleep
CountriesUnited States
CollaboratorsForest Laboratories

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 4, 2010
Enrollment StartNov 1, 2010
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 15.7 years ago

Interventions

Milnaciprandrug

50 mg twice daily

Placebodrug

50 mg twice daily