The Use of Rotigotine for Treatment of Reducing Signs and Symptoms of Fibromyalgia in Adults.
Condition: Fibromyalgia Syndrome
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Syndrome
Intervention: Rotigotine; Rotigotine; Placebo
Intervention description: Titration by Week 4 to two 20 cm2 patches (one placebo patch and one 4 mg/24 hrs patch); Titration by Week 4 to two 20 cm2 patches (both are 4 mg/24 hrs patches); 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 MeSH terms: Rotigotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 230.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Fibromyalgia Syndrome; Rotigotine; Neupro

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.
    

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