Phase 2
Completed N=230
The Use of Rotigotine for Treatment of Reducing Signs and Symptoms of Fibromyalgia in Adults.
Source: ClinicalTrials.gov NCT00464737 ↗Enrolled (actual)
230
Serious AEs
2.6%
Results posted
Jan 2010
Primary outcomePrimary: 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) — -1.12; -1.27; -0.83 Score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
-1.12; -1.27; -0.83 | — |
| PRIMARY 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) |
-1.28; -2.09; -1.57 | — |
| SECONDARY Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score to the Last Assessment in the 12-week Treatment Phase |
-14.9; -13.4; -12.8 | — |
| SECONDARY Change From Baseline in Total Myalgic Score to the Last Assessment in the 12-week Treatment Phase |
— | — |
| SECONDARY Change From Baseline in Average Daily Interference With Sleep to the Last 2 Weeks of the 12-week Treatment Phase |
-0.95; -0.82; -0.48 | — |
| SECONDARY Change From Baseline in Daily Interference With General Activity to the Last 2 Weeks of the 12-week Treatment Phase |
-1.11; -1.19; -0.88 | — |
| SECONDARY Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase |
8; 10; 9; 14; 14; 7 | — |
| SECONDARY Change From Baseline in Morning and Evening Pain Scores to the Last 2 Weeks of the 12-week Treatment Phase |
-1.07; -1.30; -0.78; -1.17; -1.24; -0.88 | — |
| SECONDARY Number of Subjects Using Rescue Medication and Alcohol During the 12-week Treatment Phase |
— | — |
| SECONDARY Rotigotine Plasma Concentration at the End of the Maintenance Phase/Week 12 |
0.2388; 0.2981 | — |
| SECONDARY Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores to the Last Assessment in the 12-week Treatment Phase |
— | — |
| SECONDARY Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase |
— | — |
| SECONDARY Change From Baseline in Beck Depression Inventory-II (BDI-II) Scores to the Last Assessment in the 12-week Treatment Phase |
— | — |
| SECONDARY Number of Subjects With Presence of Impulse Control Disorders |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT00464737). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.