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

2014-08-27 03:38:56 | BioPortfolio

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.

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

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Fibromyalgia Syndrome

Intervention

Rotigotine, Rotigotine, Placebo

Location

Mobile
Alabama
United States
85381

Status

Completed

Source

UCB, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:38:56-0400

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Medical and Biotech [MESH] Definitions

A common nonarticular rheumatic syndrome characterized by myalgia and multiple points of focal muscle tenderness to palpation (trigger points). Muscle pain is typically aggravated by inactivity or exposure to cold. This condition is often associated with general symptoms, such as sleep disturbances, fatigue, stiffness, HEADACHES, and occasionally DEPRESSION. There is significant overlap between fibromyalgia and the chronic fatigue syndrome (FATIGUE SYNDROME, CHRONIC). Fibromyalgia may arise as a primary or secondary disease process. It is most frequent in females aged 20 to 50 years. (From Adams et al., Principles of Neurology, 6th ed, p1494-95)

A syndrome characterized by persistent or recurrent fatigue, diffuse musculoskeletal pain, sleep disturbances, and subjective cognitive impairment of 6 months duration or longer. Symptoms are not caused by ongoing exertion; are not relieved by rest; and result in a substantial reduction of previous levels of occupational, educational, social, or personal activities. Minor alterations of immune, neuroendocrine, and autonomic function may be associated with this syndrome. There is also considerable overlap between this condition and FIBROMYALGIA. (From Semin Neurol 1998;18(2):237-42; Ann Intern Med 1994 Dec 15;121(12): 953-9)

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

A gamma-aminobutyric acid (GABA) derivative that functions as a CALCIUM CHANNEL BLOCKER and is used as an ANTICONVULSANT as well as an ANTI-ANXIETY AGENT. It is also used as an ANALGESIC in the treatment of NEUROPATHIC PAIN and FIBROMYALGIA.

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