A Double-Blind Multicenter Proof of Concept Trial to Assess the Efficacy and Safety of Rotigotine in Subjects With Fibromyalgia Syndrome - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00464737

Purpose

This trial investigates the efficacy and safety of 4mg/day and 8mg/day of rotigotine as compared to placebo in reducing signs and symptoms of fibromyalgia syndrome.

Condition	Intervention	Phase
Fibromyalgia Syndrome	Drug: Rotigotine Other: placebo	Phase II

MedlinePlus related topics: Fibromyalgia

Drug Information available for: Rotigotine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Parallel, Randomized, Double-Blind, Placebo-Controlled, Multicenter Proof of Concept Trial to Assess the Efficacy and Safety of 2 Different Transdermal Doses of Rotigotine in Subjects With Signs and Symptoms Associated With Fibromyalgia Syndrome

Further study details as provided by UCB:

Primary Outcome Measures:

The primary variable is the average daily pain score using an 11-point Likert scale. [ Time Frame: duration of the trial ]

Secondary Outcome Measures:

Fibromyalgia Impact Questionnaire [ Time Frame: duration of the trial ]
Total myalgic score [ Time Frame: duration of the trial ]
Daily interference with sleep. [ Time Frame: duration of the trial ]
Daily interference with general activity [ Time Frame: duration of the trial ]
Patient Global Impression of Change [ Time Frame: duration of the trial ]
Average morning and evening pain scores [ Time Frame: duration of the trial ]
Use of rescue medication [ Time Frame: duration of the trial ]
Plasma concentrations of rotigotine [ Time Frame: duration of the trial ]
Assessments of adverse events [ Time Frame: duration of the trial ]
Changes in Hospital Anxiety Depression Scale [ Time Frame: duration of the trial ]
Fibromyalgia symptom checklist [ Time Frame: duration of the trial ]
Laboratory parameters [ Time Frame: duration of the trial ]
Vital signs [ Time Frame: duration of the trial ]
ECGs [ Time Frame: duration of the trial ]
Physical Examinations [ Time Frame: duration of the trial ]
Beck Depression Inventory-II [ Time Frame: duration of the trial ]
Presence of impulse control disorders [ Time Frame: duration of the trial ]

Estimated Enrollment:	480
Study Start Date:	March 2007
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Placebo	Other: placebo placebo patch
2: Experimental 4 mg/24 hrs	Drug: Rotigotine 4mg/24 hrs Daily
3: Experimental 8mg/24hrs	Drug: Rotigotine 8mg/24hrs patch daily

Detailed Description:

This trial investigates the efficacy and safety of 4mg/day and 8mg/day of rotigotine as compared to placebo in reducing signs and symptoms of fibromyalgia syndrome.

After screening, the trial consists of 1 week Baseline Diary, 4 week Titration, 8 week double-blind Maintenance, 1 week Taper and 2 week Safety Follow-Up phases. Subjects are randomized to one of three treatment arms: rotigotine 4mg/day, 8mg/day or placebo.

The primary variable is the average daily pain score using an 11-point Likert scale.

Secondary variables include changes in Fibromyalgia Impact Questionnaire, total myalgic score, daily interference with sleep, daily interference with general activity, Patient Global Impression of Change, average morning/evening pain scores.

Other variables include: use of rescue medication, plasma concentrations of rotigotine, assessments of adverse events (including withdrawals), changes in Hospital Anxiety Depression Scale, fibromyalgia symptom checklist, laboratory parameters, vital signs, ECGs, physical examinations, Beck Depression Inventory-II, and presence of impulse control disorders.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject must have signs and symptoms of idiopathic/primary fibromyalgia that is documented as lasting ≥ 3 months

Exclusion Criteria:

Subject has symptomatic regional or structural rheumatic disease (eg, knee or hip OA, bursitis, tendonitis), rheumatic autoimmune disease or inflammatory rheumatic disease, such as SLE. Mild primary OA of the hand(s) is allowed
Subject has diagnosed neuropathic pain syndrome
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 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 BP from supine to standing position of ≥20mmHg in SBP or of ≥10mmHg in DBP taken from the 5-minute supine value and the 1- and/or 3-minute standing measurements, or supine SBP <105mmHg at Baseline

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00464737

Show 36 Study Locations

Sponsors and Collaborators

UCB

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	SP888
Study First Received:	April 23, 2007
Last Updated:	December 12, 2008
ClinicalTrials.gov Identifier:	NCT00464737
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Dopamine
Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases

Myofascial Pain Syndromes
Fibromyalgia
Pain
Rheumatic Diseases
N 0437

Additional relevant MeSH terms:

Neurotransmitter Agents
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action
Syndrome

Physiological Effects of Drugs
Nervous System Diseases
Dopamine Agents
Dopamine Agonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009