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Sponsored by: |
Kyowa Hakko Kirin Company, Limited |
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Information provided by: | Kyowa Hakko Kirin Company, Limited |
ClinicalTrials.gov Identifier: | NCT00955318 |
The purpose of this study is to evaluate the safety and efficacy of KW-6500 when administered as long-term subcutaneous self-injections in Parkinson's disease patients with motor response complications on levodopa therapy.
Condition | Intervention | Phase |
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Parkinson's Disease |
Drug: KW-6500 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase 3 Study of KW-6500 (Safety Study for Long-Term Self-Administration at Home in Patients With Parkinson's Disease |
Study Start Date: | July 2009 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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KW-6500: Experimental |
Drug: KW-6500
Subcutaneous injection of 1to 6 mg of KW-6500 for the OFF state
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Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Clinical Science Department | clinical.info@kyowa-kirin.co.jp |
Japan | |
Recruiting | |
Tokyo, Japan |
Study ID Numbers: | 6500-003 |
Study First Received: | August 7, 2009 |
Last Updated: | September 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00955318 History of Changes |
Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Ganglion Cysts Movement Disorders Parkinson Disease Basal Ganglia Diseases Central Nervous System Diseases |
Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases Apomorphine |
Movement Disorders Parkinson Disease Nervous System Diseases Basal Ganglia Diseases |
Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases |