The Use of Rotigotine for Treatment of Reducing Signs and Symptoms of Fibromyalgia in Adults. (SP888)

• ClinicalTrials.gov Identifier: NCT00464737
• Recruitment Status: Completed
• First Posted: April 24, 2007
• Results First Posted: January 5, 2010
• Last Update Posted: June 22, 2015
• Sponsor: UCB Pharma
• Information provided by (Responsible Party): UCB Pharma

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Fibromyalgia Syndrome	Drug: Rotigotine; Other: Placebo	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 230 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: March 2007
• Actual Primary Completion Date: November 2008
• Actual Study Completion Date: November 2008

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo; Placebo	Other: Placebo; Titration by Week 4 to two 20 cm2 placebo patches. At all weeks, placebo patches are matched in size and appearance to active patches.
Experimental: Rotigotine 4 mg; 4 mg/24 hrs	Drug: Rotigotine; Titration by Week 4 to two 20 cm2 patches (one placebo patch and one 4 mg/24 hrs patch); Other Name: Neupro
Experimental: Rotigotine 8 mg; 8 mg/24 hrs	Drug: Rotigotine; Titration by Week 4 to two 20 cm2 patches (both are 4 mg/24 hrs patches); Other Name: Neupro

Outcome Measures

Primary Outcome Measures :

1. 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) [ Time Frame: Baseline, Last 2 weeks of the 12-week Treatment Phase ]
   The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).
2. 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) [ Time Frame: Baseline, Last 2 weeks of the 12-week Treatment Phase ]
   The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).

Secondary Outcome Measures :

1. Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score to the Last Assessment in the 12-week Treatment Phase [ Time Frame: Baseline, Last assessment in the 12-week Treatment Phase ]
   The Fibromyalgia Impact Questionnaire (FIQ) Total Score ranges from 0 to 100 with higher scores corresponding to a greater impact of fibromyalgia
2. Change From Baseline in Total Myalgic Score to the Last Assessment in the 12-week Treatment Phase [ Time Frame: Baseline, Last assessment in the 12-week Treatment Phase ]
   Total Myalgic Score ranges from 0 to 54 with higher scores corresponding to a greater level of pain.
3. Change From Baseline in Average Daily Interference With Sleep to the Last 2 Weeks of the 12-week Treatment Phase [ Time Frame: Baseline, Last 2 weeks of the 12-week Treatment Phase ]
   Sleep scale - the subject rated quality of sleep, from 0 (very good sleep) to 10 (very poor sleep)
4. Change From Baseline in Daily Interference With General Activity to the Last 2 Weeks of the 12-week Treatment Phase [ Time Frame: Baseline, Last 2 weeks of the 12-week Treatment Phase ]
   General activity scale - the subject rated how the pain had interfered with general activity, from 0 (did not interfere) to 10 (completely interfered)
5. Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase [ Time Frame: Baseline, Last assessment in the 12-week Treatment Phase ]
   The PGIC is a 7-point self-administered categorical rating scale in which the subject rated the change in pain since starting trial medication (from much worse [score of 1] to much better [score of 7]).
6. Change From Baseline in Morning and Evening Pain Scores to the Last 2 Weeks of the 12-week Treatment Phase [ Time Frame: Baseline, Last 2 weeks of the 12-week Treatment Phase ]
   An 11-point Likert scale was used for subjects to assess pain, from 0 (no pain) to 10 (worst pain ever experienced).
7. Number of Subjects Using Rescue Medication and Alcohol During the 12-week Treatment Phase [ Time Frame: 12-week Treatment Phase ]
   Subjects recorded use of rescue medication for pain in the diary daily in the evening with a Yes/No response. Use of alcohol to treat pain in the past 24 hours was recorded with a Yes/No response.
8. Rotigotine Plasma Concentration at the End of the Maintenance Phase/Week 12 [ Time Frame: End of the Maintenance Phase/Week 12 ]
9. Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores to the Last Assessment in the 12-week Treatment Phase [ Time Frame: Baseline, Last assessment in the 12-week Treatment Phase ]
   The Hospital Anxiety and Depression Scale (HADS) is a self-administered instrument for detecting anxiety and depression in medical outpatients. Scores range from 0 to 21 for each subscale with higher scores reflecting a greater level of anxiety or depression.
10. Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase [ Time Frame: Baseline, Last assessment in the 12-week Treatment Phase ]
    All scores range from 0 to 10 with higher scores corresponding to a greater level of symptom severity.
11. Change From Baseline in Beck Depression Inventory-II (BDI-II) Scores to the Last Assessment in the 12-week Treatment Phase [ Time Frame: Baseline, Last assessment in the 12-week Treatment Phase ]
    The Beck Depression Inventory-II is a 21-item questionnaire. Each item is scored on a scale of 0 to 3 with a total score ranging from 0 to 63. A higher total score is associated with more severe depressive symptoms.
12. Number of Subjects With Presence of Impulse Control Disorders [ Time Frame: 12-week Treatment Phase ]
    Impulse control disorders (ICDs) are a set of psychiatric disorders in which a person is unable to control strong and often harmful impulses. They are assessed in this study using the Jay Modified Minnesota Impulsive Disorders Interview (Jay Modified MIDI), which focuses on the five most common ICDs that may be associated with dopamine agonist use: compulsive buying, compulsive gambling, compulsive eating, hypersexuality and punding (performing repetitive and/or mechanical tasks).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Alabama

Mobile, Alabama, United States

United States, Arizona

Mesa, Arizona, United States

Peoria, Arizona, United States, 85381

United States, California

Santa Ana, California, United States, 92705

United States, Connecticut

Cromwell, Connecticut, United States, 06416

United States, Florida

Deland, Florida, United States, 32720

Fort Myers, Florida, United States

Gainesville, Florida, United States, 32611

Ocala, Florida, United States

Orlando, Florida, United States, 32806

Palm Beach, Florida, United States

Sunrise, Florida, United States

Tampa, Florida, United States, 33606

United States, Maryland

Columbia, Maryland, United States

United States, Massachusetts

Springfield, Massachusetts, United States, 01103

United States, Missouri

St. Louis, Missouri, United States, 63141

United States, New Jersey

Stratford, New Jersey, United States

United States, New Mexico

Albuquerque, New Mexico, United States

United States, New York

New York, New York, United States, 10022

Rochester, New York, United States

Williamsville, New York, United States

United States, North Carolina

Charlotte, North Carolina, United States

Raleigh, North Carolina, United States, 27612

United States, Ohio

Cleveland, Ohio, United States, 44122

Dayton, Ohio, United States, 45408

United States, Oklahoma

Oklahoma City, Oklahoma, United States, 73112

United States, Oregon

Portland, Oregon, United States

United States, Pennsylvania

Souderton, Pennsylvania, United States

United States, Tennessee

Crossville, Tennessee, United States

United States, Texas

Dallas, Texas, United States

San Antonio, Texas, United States

United States, Utah

Bountiful, Utah, United States

United States, Vermont

Woodstock, Vermont, United States, 05091

United States, Virginia

Richmond, Virginia, United States

United States, Washington

Seattle, Washington, United States, 98104

Sponsors and Collaborators

UCB Pharma

Investigators

• Study Director: UCB Clinical Trial Call Center; +1 877 822 9493 (UCB)

More Information

Additional Information:

For Safety Alerts amd Recalls refer to 

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT00464737
• Other Study ID Numbers: SP888
• First Posted: April 24, 2007
• Results First Posted: January 5, 2010
• Last Update Posted: June 22, 2015
• Last Verified: September 2010

Keywords provided by UCB Pharma:

Fibromyalgia Syndrome; Rotigotine; Neupro

Additional relevant MeSH terms:

Fibromyalgia; Myofascial Pain Syndromes; Syndrome; Disease; Pathologic Processes; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Rotigotine; Dopamine Agonists; Dopamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs