Status:
COMPLETED
Relationship Between Sensory and Motor Systems in Restless Leg Syndrome
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Restless Legs Syndrome
Eligibility:
All Genders
18-80 years
Brief Summary
This study will explore what occurs between sensory and motor systems in restless legs syndrome (RLS). Patients with RLS have uncomfortable sensations in the legs, usually in the evening or early part...
Detailed Description
Background - Restless leg syndrome (RLS), a condition affecting millions of Americans, is characterized by uncomfortable sensory symptoms relived by voluntary or involuntary movements. Objectives -To ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Subjects who meet all of the following inclusion criteria at screening will be eligible to participate in the study:
- Male or female subjects aged 18 to 80.
- For patients only, diagnosed with primary RLS based on the presence of a characteristic clinical history and the IRLSSG diagnostic criteria.
- Normal physical and neurological examination.
- Subject is willing to adhere to protocol requirements as evidenced by written, informed consent.
- No clinically significant abnormalities on clinical chemistry or hematology examination at the pre-study medical evaluation.
- 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:
- History of any medical condition that can reasonably be expected to compromise scientific integrity of the study;
- Patient unwilling or unable to stop their usual mediations for RLS;
- Subjects unable or unwilling to discontinue a prohibited concomitant medication
- Subjects unwilling to sign an informed consent or to comply with protocol requirements.
- 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).
Exclusion
Key Trial Info
Start Date :
December 12 2003
Trial Type :
OBSERVATIONAL
End Date :
April 14 2009
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00074672
Start Date
December 12 2003
End Date
April 14 2009
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892