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

Phase 3TerminatedNCT00199381

Kyowa Kirin, Inc.504 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

504

Conditions

Parkinson's Disease

Interventions

IstradefyllineDRUG

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

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

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

Locations (1)

Kyowa Pharmaceutical Inc.

Princeton, New Jersey, United States

Outcomes

Primary Outcomes

Safety as Measured by Adverse Events

Investigation of the long-term tolerability and safety of istradefylline

Time frame: Every 2 months up to 32 months

Data from ClinicalTrials.gov

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