Status:
COMPLETED
A Long-Term, Safety Study With a Flexible Dose Range of KW-6002 in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy
Lead Sponsor:
Kyowa Kirin, Inc.
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE2
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- none
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
End Date :
October 1 2003
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00955045
Start Date
August 1 2002
End Date
October 1 2003
Last Update
April 25 2024
Active Locations (1)
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1
48 Centers in the US and 4 in Canada
Princeton, New Jersey, United States, 08540