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NCT00199368 Clinical Trial

An Extension of Istradefylline in Parkinson's Disease Patients Who Have Completed Studies 6002-EU-007, 6002-US-013 or 6002-US-018

Parkinson's Disease Clinical Trial

Official title:
A Long-Term, Multicenter, Open-Label Safety Study With Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa Therapy.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00199368
Other study ID # 6002-INT-001
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 2004
Est. completion date May 2007

Study information
Verified date April 2024
Source Kyowa Kirin Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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-year, long-term open safety study with a starting istradefylline dose of 40mg per day.

Recruitment information / eligibility
Status Completed
Enrollment 1100
Est. completion date May 2007
Est. primary completion date March 2007
Accepts healthy volunteers No
Gender All
Age group 30 Years and older
Eligibility Inclusion Criteria: - 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 Criteria: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Istradefylline ( KW-6002)

Locations
Country Name City State
United States Kyowa Pharmaceutical Inc. Princeton New Jersey

Sponsors (2)
Lead Sponsor Collaborator
Kyowa Kirin, Inc. Kyowa Hakko Kirin UK, Ltd.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety
Secondary Safety
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