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

NCT00464737 | Completed Phase 2 Results

• 1 other identifier: SP888
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 35

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.

Conditions

Fibromyalgia Syndrome

Keywords

Fibromyalgia Syndrome; Rotigotine; Neupro

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Full Analysis Set)

  The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).

  Baseline, Last 2 weeks of the 12-week Treatment Phase

• Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Per Protocol Set)

  The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).

  Baseline, Last 2 weeks of the 12-week Treatment Phase

Secondary Outcomes (12)

• Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score to the Last Assessment in the 12-week Treatment Phase

  Baseline, Last assessment in the 12-week Treatment Phase

• Change From Baseline in Total Myalgic Score to the Last Assessment in the 12-week Treatment Phase

  Baseline, Last assessment in the 12-week Treatment Phase

• Change From Baseline in Average Daily Interference With Sleep to the Last 2 Weeks of the 12-week Treatment Phase

  Baseline, Last 2 weeks of the 12-week Treatment Phase

• Change From Baseline in Daily Interference With General Activity to the Last 2 Weeks of the 12-week Treatment Phase

  Baseline, Last 2 weeks of the 12-week Treatment Phase

• Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase

  Baseline, Last assessment in the 12-week Treatment Phase

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Rotigotine 4 mg

EXPERIMENTAL

4 mg/24 hrs

Drug: Rotigotine

Rotigotine 8 mg

EXPERIMENTAL

8 mg/24 hrs

Drug: Rotigotine

Interventions

Rotigotine DRUG

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

Also known as: Neupro

Rotigotine 4 mg

Placebo 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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Pharma: lead

Study Sites (35)

Unknown Facility

Mobile, Alabama, United States

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Mesa, Arizona, United States

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Peoria, Arizona, 85381, United States

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Santa Ana, California, 92705, United States

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Cromwell, Connecticut, 06416, United States

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DeLand, Florida, 32720, United States

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Fort Myers, Florida, United States

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Gainesville, Florida, 32611, United States

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Ocala, Florida, United States

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Orlando, Florida, 32806, United States

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Palm Beach, Florida, United States

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Sunrise, Florida, United States

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Tampa, Florida, 33606, United States

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Columbia, Maryland, United States

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Springfield, Massachusetts, 01103, United States

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St Louis, Missouri, 63141, United States

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Stratford, New Jersey, United States

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Albuquerque, New Mexico, United States

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New York, New York, 10022, United States

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Rochester, New York, United States

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Williamsville, New York, United States

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Charlotte, North Carolina, United States

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Raleigh, North Carolina, 27612, United States

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Cleveland, Ohio, 44122, United States

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Dayton, Ohio, 45408, United States

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Oklahoma City, Oklahoma, 73112, United States

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Portland, Oregon, United States

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Souderton, Pennsylvania, United States

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Crossville, Tennessee, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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Bountiful, Utah, United States

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Woodstock, Vermont, 05091, United States

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Richmond, Virginia, United States

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Seattle, Washington, 98104, United States

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Related Links

• For Safety Alerts amd Recalls refer to

MeSH Terms

Conditions

Fibromyalgia

Interventions

rotigotine

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

• Title: UCB Clinical Trial Call Center
• Organization: UCB

+1 877 822 9493

Study Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2007
• First Posted: April 24, 2007
• Study Start: March 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: June 22, 2015
• Results First Posted: January 5, 2010

Record last verified: 2010-09

Locations

US (35)