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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00654498 |
To determine efficacy and safety of Pramipexole 0.125mg to 0.75mg daily for 6 weeks compared to placebo in the treatment of idiopathic Restless Legs Syndrome (RLS)
Condition | Intervention | Phase |
---|---|---|
Restless Legs Syndrome |
Drug: Pramipexole Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-blind, Placebo Controlled Dose Titration Trial With 0.125-0.75mg Pramipexole (Sifrol) Orally q.n. to Investigate the Safety and Efficacy in Out-patients With Idiopathic Restless Legs Syndrome for 6 Weeks |
Enrollment: | 305 |
Study Start Date: | March 2008 |
Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Concomitant or previous pharmacologically therapy of RLS as follows:
China | |
248.630.02 Boehringer Ingelheim Investigational Site | |
Shanghai, China | |
248.630.03 Boehringer Ingelheim Investigational Site | |
Shanghai, China | |
248.630.04 Boehringer Ingelheim Investigational Site | |
Beijing, China | |
248.630.05 Boehringer Ingelheim Investigational Site | |
Beijing, China | |
248.630.06 Boehringer Ingelheim Investigational Site | |
Beijing, China | |
248.630.07 Boehringer Ingelheim Investigational Site | |
Beijing, China | |
248.630.08 Boehringer Ingelheim Investigational Site | |
Beijing, China | |
248.630.09 Boehringer Ingelheim Investigational Site | |
Nanjing, China | |
248.630.12 Boehringer Ingelheim Investigational Site | |
Qingdao, China | |
248.630.11 Boehringer Ingelheim Investigational Site | |
Xian, Shanxi Province, China | |
248.630.13 Boehringer Ingelheim Investigational Site | |
Wuhan, China | |
248.630.14 Boehringer Ingelheim Investigational Site | |
Haerbin, China | |
248.630.15 Boehringer Ingelheim Investigational Site | |
Guangzhou, China | |
248.630.01 Boehringer Ingelheim Investigational Site | |
Shanghai, China | |
248.630.16 Boehringer Ingelheim Investigational Site | |
Suzhou, China | |
248.630.10 Boehringer Ingelheim Investigational Site | |
Hangzhou, China |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 248.630 |
Study First Received: | March 27, 2008 |
Last Updated: | July 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00654498 History of Changes |
Health Authority: | China: State Food and Drug Administration |
Neurotransmitter Agents Antioxidants Sleep Disorders Dyssomnias Psychomotor Agitation Dopamine Agonists Dyskinesias Pramipexol |
Sleep Disorders, Intrinsic Signs and Symptoms Dopamine Mental Disorders Restless Legs Syndrome Neurologic Manifestations Dopamine Agents Neurobehavioral Manifestations |
Neurotransmitter Agents Antioxidants Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Sleep Disorders Antiparkinson Agents Psychomotor Agitation Dopamine Agonists Pramipexol Sleep Disorders, Intrinsic Signs and Symptoms Pathologic Processes Mental Disorders Therapeutic Uses |
Syndrome Restless Legs Syndrome Psychomotor Disorders Neurobehavioral Manifestations Disease Parasomnias Nervous System Diseases Dyssomnias Dyskinesias Protective Agents Pharmacologic Actions Neurologic Manifestations Dopamine Agents Central Nervous System Agents |