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Sponsors and Collaborators: |
Sleep Health Centers UCB |
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Information provided by: | Sleep Health Centers |
ClinicalTrials.gov Identifier: | NCT00247364 |
To define the effective dose and tolerability of levetiracetam in individuals with Restless Legs Syndrome (RLS).
It is hypothesized that levetiracetam will be well tolerated, safe and effective in treating the symptoms of RLS.
Condition | Intervention | Phase |
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Restless Legs Syndrome |
Drug: Levetiracetam (Keppra) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Double Blind Crossover Trial of Levetiracetam (Keppra®) and Placebo in the Treatment of Restless Legs Syndrome (RLS) |
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Diagnosed with idiopathic RLS according to the four IRLSSG diagnostic criteria
Exclusion Criteria:
United States, Massachusetts | |
Sleep Health Centers | |
Newton, Massachusetts, United States, 02459 |
Principal Investigator: | John W Winkelman, MD, PhD | Sleep Health Centers, Brigham and Women's Hosptial |
Study ID Numbers: | 2003-P-001804 |
Study First Received: | October 28, 2005 |
Last Updated: | October 28, 2005 |
ClinicalTrials.gov Identifier: | NCT00247364 History of Changes |
Health Authority: | United States: Institutional Review Board |
RLS |
Nootropic Agents Sleep Disorders Dyssomnias Psychomotor Agitation Neuroprotective Agents Dyskinesias Sleep Disorders, Intrinsic Signs and Symptoms |
Mental Disorders Restless Legs Syndrome Neurologic Manifestations Piracetam Etiracetam Neurobehavioral Manifestations Anticonvulsants |
Physiological Effects of Drugs Sleep Disorders Psychomotor Agitation Neuroprotective Agents Sleep Disorders, Intrinsic Signs and Symptoms Pathologic Processes Mental Disorders Syndrome Therapeutic Uses Restless Legs Syndrome Psychomotor Disorders Neurobehavioral Manifestations |
Nootropic Agents Disease Parasomnias Nervous System Diseases Dyssomnias Dyskinesias Protective Agents Pharmacologic Actions Neurologic Manifestations Piracetam Etiracetam Central Nervous System Agents Anticonvulsants |