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

Phase 3

Terminated

• Conditions: Parkinson's Disease
• Interventions: Drug: Istradefylline

• Registration Number: NCT00199381
• Lead Sponsor: Kyowa Kirin, Inc.

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

Study Timeline

• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Study Start: 2005-10
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Disposition First Submitted: 2011-04-04
• Disposition First Submitted QC: 2011-04-20
• Disposition First Posted: 2011-04-25
• Results First Submitted: 2013-04-04
• Results First Submitted QC: 2013-07-23
• Results First Posted: 2013-07-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-05-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 504

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Istradefylline	Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.

Primary Outcome Measures

Name	Time	Method
Safety as Measured by Adverse Events	Every 2 months up to 32 months	Investigation of the long-term tolerability and safety of istradefylline

Trial Locations

Locations (1)

Kyowa Pharmaceutical Inc.; 🇺🇸 Princeton, New Jersey, United States