Last reviewed · How we verify
A 12-week, Double Blind, Placebo-controlled, Randomized, Parallel Group, Multicenter, Fixed Dose Study to Evaluate the Efficacy and Safety of 10, 20 and 40 mg/d Oral Dose of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy.
To establish the efficacy of 10, 20 and 40 mg/d dose of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa.
Details
| Lead sponsor | Kyowa Kirin, Inc. |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 580 |
| Start date | 2004-07 |
| Completion | 2005-12 |
Conditions
- Parkinson's Disease
Interventions
- Istradefylline (KW-6002)
Primary outcomes
- To establish the efficacy of 10, 20 and 40 mg/d istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa/carbidopa.
Countries
United States