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

Trial end date:
Target enrollment:
Participant gender:
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.
Phase 2
Accepts Healthy Volunteers?
Lead Sponsor:
UCB Pharma
N 0437
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

- 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

- 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