Placebo-Controlled Double-Blind Crossover Comparative Study of KW-6500
NCT01058291 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 31
Last updated 2017-03-03
Summary
This is a placebo-controlled double-blind crossover comparative study of KW-6500 in Parkinson's disease patients with motor response complications on levodopa therapy. The efficacy of KW-6500 is evaluated using the change of UPDRS part III score at double blind period after 12 weeks subcutaneous self-injections.
Conditions
Interventions
- DRUG
-
KW-6500
Twelve weeks subcutaneous injection of 1 to 6 mg for the OFF state
- DRUG
-
KW-6500 Placebo
Twelve weeks subcutaneous injection for the OFF state
Sponsors & Collaborators
-
Kyowa Kirin Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-01-31
- Primary Completion
- 2010-10-31
- Completion
- 2010-10-31
Countries
- Japan
Study Locations
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