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The Effects of Milnacipran on Sleep Disturbance in Fibromyalgia

NCT01234675 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2019-08-21

Study results available
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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.

Conditions

  • Sleep Disorders
  • Fibromyalgia
  • Sleep

Interventions

DRUG

Milnacipran

50 mg twice daily

DRUG

Placebo

50 mg twice daily

Sponsors & Collaborators

  • Forest Laboratories

    collaborator INDUSTRY

  • Mansoor Ahmed M.D.

    lead OTHER

Principal Investigators

  • Mansoor Ahmed, MD · Cleveland Sleep Research Cneter

  • Rozina Aamir, MS, MBA · Cleveland Sleep Research Center

  • Noel Cyrill, MD · SouthWest Cleveland Sleep Center

  • Nosson S Goldfarb, M.D. · Cleveland Sleep Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01234675 on ClinicalTrials.gov