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Discontinuation Study of the Durability of Effect of Milnacipran for the Treatment of Fibromyalgia

NCT01014585 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2011-09-07

Study results available
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Summary

The purpose of this study is to evaluate the durability of effect of milnacipran for the treatment of fibromyalgia in patients receiving long-term milnacipran treatment and to characterize the effects of milnacipran on multiple symptoms of fibromyalgia, as demonstrated by changes in symptoms following the discontinuation of milnacipran.

Conditions

  • Fibromyalgia

Interventions

DRUG

Placebo

Placebo tablets administered orally twice daily

DRUG

Milnacipran

Milnacipran tablets administered orally twice daily

Sponsors & Collaborators

  • Cypress Bioscience, Inc.

    collaborator INDUSTRY

  • Forest Laboratories

    lead INDUSTRY

Principal Investigators

  • Joel Trugman, MD · Forest Research Institute Inc., A Subsidiary of Forest Laboratories Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-05-31

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 NCT01014585 on ClinicalTrials.gov