Status:
TERMINATED
An Extension of Istradefylline in North American Parkinson's Disease Patients Who Have Completed Study 6002-INT-001
Lead Sponsor:
Kyowa Kirin, Inc.
Collaborating Sponsors:
Kyowa Kirin Co., Ltd.
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- Completion of study 6002-INT-001
- Not of childbearing potential
Exclusion
- Cancer within 5 years of enrollment
- ALT/AST levels \> 2.5 times ULN
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
504 Patients enrolled
Trial Details
Trial ID
NCT00199381
Start Date
October 1 2005
End Date
October 1 2008
Last Update
May 17 2024
Active Locations (1)
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1
Kyowa Pharmaceutical Inc.
Princeton, New Jersey, United States, 08540