Status:
COMPLETED
An Extension of Istradefylline in Parkinson's Disease Patients Who Have Completed Studies 6002-EU-007, 6002-US-013 or 6002-US-018
Lead Sponsor:
Kyowa Kirin, Inc.
Collaborating Sponsors:
Kyowa Hakko Kirin UK, Ltd.
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE3
Brief Summary
This is a 1-year, open-label, long-term safety extension for patients who have completed prior istradefylline studies 6002-EU-007, 6002-US-013 or 6002-US-018.
Detailed Description
Patients with Parkinson's disease with motor complications on levodopa therapy who completed the prior double-blind studies 6002-EU-007, 6002-US-013 or 6002-US-018 are eligible to enter into this 1-ye...
Eligibility Criteria
Inclusion
- Completion of study 6002-EU-007, 6002-US-013 or 6002-US-018
- Non-pregnant and either not of childbearing potential or using specified contraception
Exclusion
- History of psychotic illness
- Variant/atypical Parkinson's disease
- Cancer within 5 years of enrollment
- ALT/AST levels \> 1.5 times ULN
- Seizure disorder
- Neuroleptic malignant syndrome
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2007
Estimated Enrollment :
1100 Patients enrolled
Trial Details
Trial ID
NCT00199368
Start Date
October 1 2004
End Date
May 1 2007
Last Update
April 25 2024
Active Locations (1)
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1
Kyowa Pharmaceutical Inc.
Princeton, New Jersey, United States, 08540