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

NCT ID: NCT00464737

Last Updated: 2015-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2008-11-30

Brief 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.

Detailed Description

The overall post-Baseline duration of treatment was 13 weeks. The trial consisted of a 4-week Titration Phase, an 8-week Maintenance Phase, a 1-week De-escalation Phase, and a 2-week Safety Follow-Up Phase. If subjects met the eligibility criteria, they were randomized to receive rotigotine 4 mg/24 hrs, rotigotine 8 mg/24 hrs, or placebo during the Maintenance Phase. During the 4-week Titration Phase, subjects assigned to rotigotine were titrated at weekly intervals of 2 mg/24 hrs until they reached 4 mg/24 hrs or 8 mg/24 hrs. All subjects who completed the 4-week Titration Phase entered an 8-week Maintenance Phase and were maintained at their randomized dose (rotigotine 4 mg/24 hrs, rotigotine 8 mg/24 hrs, or placebo). No dose adjustment was allowed during the Maintenance Phase. The Treatment Phase was defined as the combined Titration and Maintenance Phases.

Conditions

Fibromyalgia Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Rotigotine 4 mg

4 mg/24 hrs

Group Type: EXPERIMENTAL

Rotigotine

Intervention Type: DRUG

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

Rotigotine 8 mg

8 mg/24 hrs

Group Type: EXPERIMENTAL

Rotigotine

Intervention Type: DRUG

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

Interventions

Rotigotine

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

Intervention Type: DRUG

Rotigotine

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

Intervention Type: DRUG

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.

Intervention Type: OTHER

Other Intervention Names

Neupro; Neupro

Eligibility Criteria

Inclusion Criteria

• Subject is male or female, 18 to 65 years of age (inclusive)
• Subject fulfills all 3 points of the American College of Rheumatology (ACR) definition for diagnosis of fibromyalgia (pain, stiffness, and/or sleep disorder)
• Subject must complete an adequate washout period for excluded medications, as necessary, prior to beginning the Baseline Diary Phase
• Subject has at least moderate pain that is defined as an average pain intensity of ≥5 on an 11-point Likert pain scale (0-10) during the 7 days prior to Baseline
• Subject must have at least 5 morning and 5 evening Likert pain scale scores for the 7 days immediately prior to Visit 2 and the average daily pain score over these 7 days must be ≥5 (average daily pain score is determined as follows: calculate the mean of the morning and evening scores separately using all pain scores for the 7 days immediately prior to Visit 2; add the mean morning and evening scores and divide by 2)
• Subject has a score of ≥50 on Fibromyalgia Impact Questionnaire (FIQ), with a score of 100 representing severe disease at Baseline

Exclusion Criteria

• Subject has symptomatic regional or structural rheumatic disease (eg, knee or hip osteoarthritis, bursitis, tendonitis), rheumatic autoimmune disease or inflammatory rheumatic disease, such as systemic lupus erythematosus (SLE), mild primary osteoarthritis of the hand(s) is allowed
• Subject has diagnosed neuropathic pain syndrome
• Subject has received therapy with a dopamine agonist (eg, pramipexole, ropinirole) for 3 months or longer that was not considered effective in managing fibromyalgia symptoms
• Subject is receiving disability or is involved in litigation related to fibromyalgia syndrome
• Subject has significant psychopathology as determined by the investigator based on results of the Structural Clinical Interview for DSM-IV Diagnosis (SCID-I). The SCID-I must be administered by a physician or clinical psychologist trained to administer the instrument
• Subject has evidence of an impulse control disorder according to the Jay Modified Minnesota Impulsive Disorders Interview (MIDI)
• Subject has any medical condition that, in the opinion of the investigator, could jeopardize or compromise the subject's ability to participate in this trial
• Subject has orthostatic hypotension with a decrease of blood pressure (BP) from supine to standing position of ≥20 mmHg in systolic blood pressure (SBP) or of ≥10 mmHg in diastolic blood pressure (DBP) taken from the 5-minute supine value and the 1- and/or 3-minute standing measurements, or supine SBP <105 mmHg at Baseline

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

Mobile, Alabama, United States

Mesa, Arizona, United States

Peoria, Arizona, United States

Santa Ana, California, United States

Cromwell, Connecticut, United States

DeLand, Florida, United States

Fort Myers, Florida, United States

Gainesville, Florida, United States

Ocala, Florida, United States

Orlando, Florida, United States

Palm Beach, Florida, United States

Sunrise, Florida, United States

Tampa, Florida, United States

Columbia, Maryland, United States

Springfield, Massachusetts, United States

St Louis, Missouri, United States

Stratford, New Jersey, United States

Albuquerque, New Mexico, United States

New York, New York, United States

Rochester, New York, United States

Williamsville, New York, United States

Charlotte, North Carolina, United States

Raleigh, North Carolina, United States

Cleveland, Ohio, United States

Dayton, Ohio, United States

Oklahoma City, Oklahoma, United States

Portland, Oregon, United States

Souderton, Pennsylvania, United States

Crossville, Tennessee, United States

Dallas, Texas, United States

San Antonio, Texas, United States

Bountiful, Utah, United States

Woodstock, Vermont, United States

Richmond, Virginia, United States

Seattle, Washington, United States

Countries

United States

Related Links

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

For Safety Alerts amd Recalls refer to

Other Identifiers

SP888

Identifier Type: -

Identifier Source: org_study_id