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| Sponsor: | Kyowa Hakko Kirin Company, Limited |
|---|---|
| Information provided by: | Kyowa Hakko Kirin Company, Limited |
| ClinicalTrials.gov Identifier: | NCT00610103 |
Purpose
The purpose of this study is to evaluate the efficacy of KW-6500 versus placebo when administered as a subcutaneous injection at the individualized maintenance dose level in an OFF state in Parkinson's disease patients with motor response complications on levodopa therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson's Disease |
Drug: apomorphine hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 2 Clinical Study of KW-6500 (Apomorphine Hydrochloride) in Patients With Parkinson's Disease |
| Estimated Enrollment: | 15 |
| Study Start Date: | November 2007 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: KW-6500
Drug: KW-6500 (apomorphine hydrochloride (USAN))
|
Drug: apomorphine hydrochloride
Apomorphine hydrochloride (started at 1 mg and titrated to a maximum of 6 mg) is subcutaneously administered.
Other Name: KW-6500
|
|
Placebo Comparator: Placebo
Placebo
|
Drug: apomorphine hydrochloride
Apomorphine hydrochloride (started at 1 mg and titrated to a maximum of 6 mg) is subcutaneously administered.
Other Name: KW-6500
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The efficacy of KW-6500 as a subcutaneous injection at the individualized maintenance dose level (1 mg to 6 mg per dose) when used in combination with domperidone (30 mg/day) will be evaluated in comparison with that of placebo in Parkinson's disease patients with motor response complications on levodopa therapy. The maintenance dose level for each subject will be determined using a titration scheme in 1 mg increments.
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients who meet both of the following criteria on the Modified Hoehn and Yahr Scale during the preliminary evaluation and on the day before starting study drug (Day -1).
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Kyowa Hakko Kirin Company, Limited |
| ClinicalTrials.gov Identifier: | NCT00610103 History of Changes |
| Other Study ID Numbers: | 6500-0702 |
| Study First Received: | January 22, 2008 |
| Last Updated: | June 25, 2009 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
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Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Apomorphine Antiparkinson Agents |
Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |