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

Kyowa Kirin

Status and phase: Terminated; Phase 3

Conditions: Parkinson's Disease

Treatments: Drug: Istradefylline

Study type: Interventional

Funder types: Industry

Identifiers

NCT00199381

6002-US-025

Details and patient eligibility

About

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

Full 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.

Enrollment: 504 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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504 participants in 1 patient group

Single Arm

Experimental group

Description:

Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.

Treatment:

Drug: Istradefylline