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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2007-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Istradefylline ( KW-6002)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No