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Therapeutic Areas: Psychiatry/Psychology | Neurology
Disease Category: Restless Legs

Trial Information

Restless Leg Syndrome associated sleep disturbance

Three month study to evaluate the study drug(extended release tablets) compared to treatment with placebo (sugar pill)on patients with RLS associated sleep disturbance. All study exams, procedures and study medications are furnished at no cost. Patients will receive $50.00 for each completed daytime visit, and $250.00 for each completed overnight visit, for a possible total of up to $1900.00 to cover their time and travel expenses.

Patient Inclusion Criteria: Patients 18 years old or older with a diagnosis of RLS and have documented RLS symptoms for at least 4 of the 7 consecutive nights prior to starting the study, and a history of RLS symptoms at least 15 nights in the prior month, or if in treatment, at least 15 nights in the month prior to starting treatment. Patient should have a usual bedtime of approximately 10:00pm or later and can be available for overnight visits.

Patient Exclusion Criteria: Liver disease, kidney problems, sleep apnea or other sleep disorders, other than RLS. Alcohol or substance abuse/dependence within the past year, neurologic disease, Parkinson's disease, Multiple sclerosis, Rheumatoid Arthritis, fibromyalgia syndrome, psychiatric illness, severe cardiovascular disease, current diagnosis or history of Epilepsy or seizure disorder may exclude you from participating. We encourage you to call our office and speak to a research professional to see if you may qualify for this very important clinical trial. We are accepting a limited number of volunteers, so please contact us at the telephone number or email listed below.

Naomy Granger, LPN, CCRC, Clinical Research Coordinator
Gulf Coast Research Associates, Inc.
7049 Perkins Road
Baton Rouge, LA 70808
Phone: 225-757-1084
Fax: 225-757-0294
EMail: naomy@gulfcoastra.com

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If you would like to learn more about participating in this study, please send an e-mail message using the form below.

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