Sensorimotor Gating Studies in Restless Legs Syndrome

Date de début de l'étude : 12 décembre 2003

* INCLUSION CRITERIA: Subjects who meet all of the following inclusion criteria at screening will be eligible to participate in the study: 1. Male or female subjects aged 18 to 80. 2. For patients only, diagnosed with primary RLS based on the presence of a characteristic clinical history and the IRLSSG diagnostic criteria. 3. Normal physical and neurological examination. 4. Subject is willing to adhere to protocol requirements as evidenced by written, informed consent. 5. No clinically significant abnormalities on clinical chemistry or hematology examination at the pre-study medical evaluation. 6. Negative pre-study urine drug screen. EXCLUSION CRITERIA: Subjects meeting any of the following exclusion criteria will not be enrolled or will be immediately excluded from the study, as appropriate: 1. History of any medical condition that can reasonably be expected to compromise scientific integrity of the study; 2. Patient unwilling or unable to stop their usual mediations for RLS; 3. Subjects unable or unwilling to discontinue a prohibited concomitant medication 4. Subjects unwilling to sign an informed consent or to comply with protocol requirements. 5. Subjects with clinical and/or biological evidence of secondary RLS (e.g. renal failure (end-stage renal disease), iron deficient, anaemia or pregnancy at baseline).