Clinical trial

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.

NCT00199381

Name

6002-US-025

Description

This is an, open-label, long-term safety extension for patients in North America who have completed the prior istradefylline study 6002-INT-001.

Trial arms

Trial start

2005-10-01

Estimated PCD

2008-10-01

Trial end

2008-10-01

Status

Terminated

Phase

Early phase I

Treatment

Istradefylline

Oral istradefylline (KW-6002) 20 or 40 mg once daily.

Arms:

Single Arm

Other names:

KW-6002

Size

504

Primary endpoint

Safety as Measured by Adverse Events

Every 2 months up to 32 months

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 504, 'type': 'ACTUAL'}}

Updated at

2024-05-17

1 organization

1 product

1 indication

Organization

Kyowa Kirin

Product

Istradefylline

Indication

Parkinson's Disease