Clinical trial NCT00464737: The Use of Rotigotine for Treatment of Reducing Signs and Symptoms of Fibromyalgia in Adults.
Official title: A Parallel, Randomized, Double-Blind, Placebo-Controlled, Multicenter Proof of Concept Trial to Assess the Efficacy and Safety of 2 Different Doses of Rotigotine in Subjects With Signs and Symptoms Associated With Fibromyalgia Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fibromyalgia Syndrome
Keywords: Fibromyalgia Syndrome
Rotigotine
Neupro
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2007-04-24
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 Phase. If subjects met the eligibility criteria, they were randomized to receive rotigotine 4 mg/24 hrs, rotigotine 8 mg/24 hrs, or placebo during the Maintenance Phase. During the 4-week Titration Phase, subjects assigned to rotigotine were titrated at weekly intervals of 2 mg/24 hrs until they reached 4 mg/24 hrs or 8 mg/24 hrs. All subjects who completed the 4-week Titration Phase entered an 8-week Maintenance Phase and were maintained at their randomized dose (rotigotine 4 mg/24 hrs, rotigotine 8 mg/24 hrs, or placebo). No dose adjustment was allowed during the Maintenance Phase. The Treatment Phase was defined as the combined Titration and Maintenance Phases.

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

Primary outcomes:
measure: 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)
timeFrame: Baseline, Last 2 weeks of the 12-week Treatment Phase
measure: 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)
timeFrame: Baseline, Last 2 weeks of the 12-week Treatment Phase
Secondary outcomes:
measure: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score to the Last Assessment in the 12-week Treatment Phase
timeFrame: Baseline, Last assessment in the 12-week Treatment Phase
measure: Change From Baseline in Total Myalgic Score to the Last Assessment in the 12-week Treatment Phase
timeFrame: Baseline, Last assessment in the 12-week Treatment Phase
measure: Change From Baseline in Average Daily Interference With Sleep to the Last 2 Weeks of the 12-week Treatment Phase
timeFrame: Baseline, Last 2 weeks of the 12-week Treatment Phase
measure: Change From Baseline in Daily Interference With General Activity to the Last 2 Weeks of the 12-week Treatment Phase
timeFrame: Baseline, Last 2 weeks of the 12-week Treatment Phase
measure: Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase
timeFrame: Baseline, Last assessment in the 12-week Treatment Phase
measure: Change From Baseline in Morning and Evening Pain Scores to the Last 2 Weeks of the 12-week Treatment Phase
timeFrame: Baseline, Last 2 weeks of the 12-week Treatment Phase
measure: Number of Subjects Using Rescue Medication and Alcohol During the 12-week Treatment Phase
timeFrame: 12-week Treatment Phase
measure: Rotigotine Plasma Concentration at the End of the Maintenance Phase/Week 12
timeFrame: End of the Maintenance Phase/Week 12
measure: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores to the Last Assessment in the 12-week Treatment Phase
timeFrame: Baseline, Last assessment in the 12-week Treatment Phase
measure: Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase
timeFrame: Baseline, Last assessment in the 12-week Treatment Phase
measure: Change From Baseline in Beck Depression Inventory-II (BDI-II) Scores to the Last Assessment in the 12-week Treatment Phase
timeFrame: Baseline, Last assessment in the 12-week Treatment Phase
measure: Number of Subjects With Presence of Impulse Control Disorders
timeFrame: 12-week Treatment Phase
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Mesa
country: United States
state: Arizona
city: Peoria
country: United States
state: Arizona
city: Santa Ana
country: United States
state: California
city: Cromwell
country: United States
state: Connecticut
city: Deland
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Palm Beach
country: United States
state: Florida
city: Sunrise
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Columbia
country: United States
state: Maryland
city: Springfield
country: United States
state: Massachusetts
city: St. Louis
country: United States
state: Missouri
city: Stratford
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Williamsville
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Souderton
country: United States
state: Pennsylvania
city: Crossville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Bountiful
country: United States
state: Utah
city: Woodstock
country: United States
state: Vermont
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: