An Extension of Istradefylline in North American Parkinson's Disease Patients Who Have Completed Study 6002-INT-001

Parkinson's Disease Clinical Trial

Official title:

An Open-Label Multicenter Study of the Continued Safety of Istradefylline (KW-6002) In Subjects With Parkinson's Disease Who Have Recently Completed One Year of Treatment With Istradefylline.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00199381
• Other study ID #: 6002-US-025
• Status: Terminated
• Phase: Phase 3
• Start date: October 2005
• Est. completion date: October 2008

Study information

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

Clinical Trial 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.

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 a starting istradefylline dose of 20 or 40mg per day.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 504
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Completion of study 6002-INT-001

• Not of childbearing potential

Exclusion Criteria:

• Cancer within 5 years of enrollment

• ALT/AST levels > 2.5 times ULN

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Istradefylline
Oral istradefylline (KW-6002) 20 or 40 mg once daily.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Kyowa Kirin, Inc.	Kyowa Kirin Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety as Measured by Adverse Events	Investigation of the long-term tolerability and safety of istradefylline	Every 2 months up to 32 months