![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
---|---|
Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00152997 |
The objective of this trial is to investigate efficacy and safety of pramipexole (BIoSifrol) (0.125-0.75 mg) orally once daily as compared with placebo for 6 weeks in patients with primary restless legs syndrome.
Condition | Intervention | Phase |
---|---|---|
Restless Legs Syndrome |
Drug: Pramipexole 0.125 mg tablets Drug: Pramipexole 0.125 mg tablets Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
Official Title: | A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Pramipexole With the Dose Range From 0.125 mg to 0.75 mg Orally Once Daily for 6 Weeks in Patients With Primary Restless Legs Syndrome. |
Estimated Enrollment: | 42 |
Estimated Study Completion Date: | June 2006 |
Ages Eligible for Study: | 20 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
According to the essential diagnostic criteria for RLS of NIH and IRLSSG, the following four all criterias must be presented:
The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night
Exclusion Criteria:
Pre-menopausal women who meet any one of the following (1) - (3):
Japan | |
Boehringer Ingelheim Investigational Site | |
Shibuya,Tokyo, Japan | |
Boehringer Ingelheim Investigational Site | |
Takatsuki, Osaka, Japan | |
Boehringer Ingelheim Investigational Site | |
Sakai, Osaka, Japan | |
Boehringer Ingelheim Investigational Site | |
Otaru,Hokkaido, Japan | |
Boehringer Ingelheim Investigational Site | |
Akita, Akita, Japan | |
Boehringer Ingelheim Investigational Site | |
Kochi, Kochi, Japan | |
Boehringer Ingelheim Investigational Site | |
Kurume, Fukuoka, Japan |
Study Chair: | Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim Pharmaceuticals |
Study ID Numbers: | 248.557 |
Study First Received: | September 9, 2005 |
Last Updated: | November 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00152997 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare; United States: Food and Drug Administration |
Ekbom syndrome Sleep Disorders Dyssomnias Psychomotor Agitation Dyskinesias Pramipexol Sleep Disorders, Intrinsic |
Signs and Symptoms Dopamine Mental Disorders Restless Legs Syndrome Neurologic Manifestations Neurobehavioral Manifestations |
Neurotransmitter Agents Disease Antioxidants Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Nervous System Diseases Parasomnias Physiological Effects of Drugs Antiparkinson Agents |
Dopamine Agonists Protective Agents Pharmacologic Actions Pathologic Processes Therapeutic Uses Syndrome Psychomotor Disorders Dopamine Agents Central Nervous System Agents |