Trial Information

Summary: Protocol 248.616 Phase IV Randomized, Double-Blind, Active and Placebo-controlled, 6 week Trial to investigate the efficacy and safety of a starting and fixed dose 0.25 mg Pramipexole (Mirapex) in patients with idiopathic Restless Legs Syndrome

Do your restless legs keep you up at night?
Symptoms of RLS include:

• urge to move your legs
• relief when you move
• symptoms worse at rest
• symptoms worse at night

If you are not taking medication for this and are 18 years of age or older you may qualify to be in a research study. Candidates who qualify for this study will be compensated.

If interested in this study please call for more information.

Patient Inclusion Criteria

• Signed Consent.
• Male or female outpatients 18 to 80 years of age
• Diagnosis of RLS
• RLS symptoms present at least 2 to 3 days per week during the last 3 months
• IRLS rating scale score >15 at baseline

Patient Exclusion Criteria

• Women of child-bearing age who do not use an adequate method of contraception
• Any women of child-bearing potential not having negative pregnancy test at screening
• Breastfeeding women
• Concomitant or previous pharmacologic therapy for RLS
• Certain medications
• Previous pramipexole non-responders in other indications than RLS
• Confirmed diagnosis of diabetes mellitus requiring insulin therapy
• Presence of a sleep disorder
• Presence of major depressive disorder
• History of drug or alcohol abuse
• Participation in a trial within 1 month prior to the start of this study

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