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

Phase 3

Completed

• Conditions: Parkinson's Disease

• Registration Number: NCT00199368
• Lead Sponsor: Kyowa Kirin, Inc.

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

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Primary Completion: 2007-03
• Study Completion: 2007-05
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety

Secondary Outcome Measures

Name	Time	Method
Safety

Trial Locations

Locations (1)

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