Status:
COMPLETED
The Use of Rotigotine for Treatment of Reducing Signs and Symptoms of Fibromyalgia in Adults.
Lead Sponsor:
UCB Pharma
Conditions:
Fibromyalgia Syndrome
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 act...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT00464737
Start Date
March 1 2007
End Date
November 1 2008
Last Update
June 22 2015
Active Locations (35)
Enter a location and click search to find clinical trials sorted by distance.
1
Mobile, Alabama, United States
2
Mesa, Arizona, United States
3
Peoria, Arizona, United States, 85381
4
Santa Ana, California, United States, 92705