Conditions: Parkinson's Disease
Keywords: Parkinson's Disease levodopa end of dose wearing off OFF time
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 504
Healthy volunteers: no

Brief summary:
This is an, open-label, long-term safety extension for patients in North America who have completed the prior istradefylline study 6002-INT-001.

Detailed description:
Patients with Parkinson's disease with motor complications on levodopa therapy who completed the prior double-blind study 6002-INT-001 are eligible to enter into this long-term open safety study with a starting istradefylline dose of 20 or 40mg per day.

Arms:
arm 1: Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.

Interventions: intervention 1: Istradefylline
Intervention descriptions: intervention 1: Oral istradefylline (KW-6002) 20 or 40 mg once daily.

Protocol document: