A Long-Term, Safety Study With a Flexible Dose Range of KW-6002 in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy

• Status: Completed
• Trial end date: 2003-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study was to establish the long-term tolerability and safety of istradefylline treatment in subjects with Parkinson's disease treated with levodopa/carbidopa. In addition, treatment response and maintenance of response were assessed.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Kirin Pharmaceutical Development, Inc.; Kyowa Kirin, Inc.
• Treatments: Carbidopa; Istradefylline; Levodopa

Criteria

Inclusion Criteria:

Eligible subjects were:

• male or female

• at least 30 years of age

• had completed participation in a prior double-blind istradefylline trial

• met United Kingdom's Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and Step 2) for Parkinson's disease and the severity of the Parkinson's disease was defined as Stages 2-4 on the Modified Hoehn and Yahr Scale while in the OFF state

• had been treated with levodopa for at least 1 year

• had been on a stable Parkinson's disease regimen within normal therapeutic ranges including levodopa for at least 4 weeks before Baseline

• were currently taking at least 4 doses of levodopa per day (3 doses per day if at least 2 doses contained slow-release formulation)

• had predictable end-of-dose wearing-off

Exclusion Criteria:

• none