Trial Information

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

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

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.

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

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Trial listings updated: June 1, 2008 at 6:43:11 AM