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The Use of Rotigotine for Treatment of Reducing Signs and Symptoms of Fibromyalgia in Adults.

NCT00464737 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2015-06-22

Study results available
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Summary

This trial is to investigate the efficacy and safety of rotigotine as compared to placebo in reducing signs and symptoms of fibromyalgia syndrome. The effects of rotigotine on pain, sleep, general activity, mood, and quality of life, and the use of rescue medication to treat pain will be assessed.

Conditions

  • Fibromyalgia Syndrome

Interventions

DRUG

Rotigotine

Titration by Week 4 to two 20 cm2 patches (one placebo patch and one 4 mg/24 hrs patch)

DRUG

Rotigotine

Titration by Week 4 to two 20 cm2 patches (both are 4 mg/24 hrs patches)

OTHER

Placebo

Titration by Week 4 to two 20 cm2 placebo patches. At all weeks, placebo patches are matched in size and appearance to active patches.

Sponsors & Collaborators

  • UCB Pharma

    lead INDUSTRY

Principal Investigators

  • UCB Clinical Trial Call Center · +1 877 822 9493 (UCB)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • United States

Study Locations

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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 NCT00464737 on ClinicalTrials.gov