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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00390689 |
The objective of double blind phase in this trial is to compare the efficacy and safety at the fixed dose of 0.25 mg,0.5 mg and 0.75 mg pramipexole in RLS. The objective of open label phase in this tr ial is to investigate the long term safety and efficacy of pramipexole in RLS.
Condition | Intervention | Phase |
---|---|---|
Restless Legs Syndrome |
Drug: Pramipexole 0.125 mg tablet Drug: Pramipexole 0.5 mg tablet |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety Study |
Official Title: | A Randomised, Double Blind Study Comparing Fixed Doses of 0.25mg, 0.5mg and 0.75mg Pramipexole to Investigate the Efficacy and Safety in Patients With Idiopathic Restless Legs Syndrome for 6 Weeks, Followed by 46 Weeks Open Label Long Term Study to Investigate the Safety and Efficacy of Pramipexole |
Enrollment: | 154 |
Study Start Date: | October 2006 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 20 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with a diagnosis of RLS according to the following diagnosis criteria of NIH/IRLSSG:
Exclusion Criteria:
Japan | |
Yoyogi Somnological Clinic, NEURO Inst | |
Shibuya-ku, Tokyo, Japan | |
Han-nan hospital | |
Sakai,Osaka, Japan | |
Kurume University Hospital | |
Kurume, Fukuoka, Japan | |
Ishikane Hospital | |
Sapporo, Hokkaido, Japan | |
Wellness Boyo Clinic | |
Otaru, Hokkaido, Japan | |
Aoba Hospital | |
Sendai, Miyagi, Japan | |
Yokohama city minato Red Cross Hospital | |
Kanagawa, Yokohama, Japan | |
Kawashima Neurology Clinic | |
Fujisawa, Kanagawa, Japan | |
Kume Clinic | |
Nagoya, Aichi, Japan | |
Toyohashi Mates Daini Clinic | |
Toyohashi,?Aichi, Japan | |
Kyotani clinic | |
Osaka, Osaka, Japan | |
Osaka Medical College Hospital | |
Takatsuki,Osaka, Japan | |
Kochi Kagamigawa Hospital | |
Kochi,Kochi, Japan | |
K-you health care Co. Kirigaoka tsuda hospital | |
Kitakyusyu, Fukuoka, Japan | |
You Clinic | |
Kitakyusyu, Fukuoka, Japan | |
Kyorin University Hospital | |
Mitaka-shi, Tokyo, Japan | |
Shiga University of Medical Science Hospital | |
Otsu, Shiga, Japan | |
Southern TOHOKU Research Institute for Neuroscience Southern | |
Koriyama, Fukushima, Japan | |
SAINO clinic | |
Tokorozawa, Saitama, Japan | |
Fukuoka Urasoe Clinic | |
Fukuoka, Fukuoka, Japan | |
Takaoka Hospital | |
Kagoshima, Kagoshima, Japan | |
Nakamura Clinic | |
Urasoe, Okinawa, Japan | |
Tokunaga Clinic Respiration&Sleep | |
Hiroshima, Hiroshima, Japan | |
Tokushima?University Hospital | |
Tokushima, Tokushima, Japan | |
Miura Mental Clinic | |
Sapporo, Hokkaido, Japan | |
Dokkyo University Hospital | |
Shimotsuga-gun,Tochigi, Japan | |
Kanazawa-ekimae GUSSURI Clinic | |
Kanazawa, Ishikawa, Japan | |
Musashi Clinic | |
Kodaira, Tokyo, Japan | |
Jikei University School of Medicine Hospital | |
Minato-ku, Tokyo, Japan | |
Aichi Medical University Hospital | |
Aichi-gun, Aichi, Japan | |
Ohta Nishinouchi Hospital | |
Koriyama, Fukushima, Japan | |
Kuwamizu hospital | |
Kumamoto, Kumamoto, Japan | |
Yotsuya International Medicine Clinic | |
Shinjuku-ku, Tokyo, Japan | |
Ota Memorial Sleep Center | |
Kawasaki, Kanagawa, Japan |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 248.627 |
Study First Received: | October 19, 2006 |
Last Updated: | July 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00390689 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
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 |