NCT01234675

The Effects of Milnacipran on Sleep Disturbance in Fibromyalgia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Mansoor Ahmed M.D. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The sleep disturbance in fibromyalgia is characterized as non-restorative in nature, and is defined as a feeling of light sleep, independent of duration, and as non-refreshing. As such, these patients wake up in the morning and complain of stiffness and overall aching of the body. It is well known that reciprocal relationship exists between sleep and pain, with sleep disturbances being an important contributor to morbidity in fibromyalgia. Milnacipran, a selective serotonin norepinephrine receptor inhibitor (SNRI), was approved by the Food and Drug Administration (FDA) for the management of fibromyalgia. Although milnacipran has extensively been studied in fibromyalgia patients, but there is no objective measure, i.e., the use of overnight polysomnography, to determine its effects on sleep. The study was undertaken to evaluate the effects of milnacipran on PSG determined measures of sleep in patients with fibromyalgia. The study also evaluated the impact of milnacipran on subjective measures of sleep and fibromyalgia symptoms.

Conditions

• Sleep Disorders
• Fibromyalgia
• Sleep

Interventions

Type	Name	Description
DRUG	Milnacipran	50 mg twice daily
DRUG	Placebo	50 mg twice daily

Timeline

• Start date: 2010-11-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2010-11-04
• Last updated: 2019-08-21
• Results posted: 2015-07-22

Locations

1 site across 1 country: United States