A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease

Last updated: April 23, 2024
Sponsor: Kyowa Kirin Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Parkinson's Disease

Dyskinesias

Treatment

Istradefylline (KW-6002)

Clinical Study ID

NCT00199394
6002-EU-007
  • Ages > 30
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy of 40 mg a day of istradefylline (KW-6002) for reducing the percentage of awake time spent in the OFF state in patients with advanced Parkinson's disease treated with levodopa.

Eligibility Criteria

Inclusion

Inclusion Criteria: Patients selected for this study will be at least 30 years of age and will have beendiagnosed with advanced Parkinson's disease as determined by UK Parkinson's Disease Society (UKPDS) criteria and the Modified Hoehn and Yahr Scale. The patients will have beenreceiving levodopa treatment for at least one year, may be taking other antiparkinsoniandrugs, will have an average of at least three hours OFF time as recorded in two 24-hourON/OFF diaries, and if female, must be non-pregnant and non-nursing.

Exclusion

Exclusion Criteria: Patients may not be enrolled if they are taking certain medications excluded by theprotocol, have been treated with any investigational drug within 30 days prior torandomisation (or five half-lives if longer), have ever received istradefylline or beentreated with a COMT inhibitor, are psychotic, have clinically significant illness orlaboratory values at screening, have insufficient mental capacity to comply with protocolrequirements or certain psychiatric or neurological conditions.

Study Design

Total Participants: 405
Treatment Group(s): 1
Primary Treatment: Istradefylline (KW-6002)
Phase: 3
Study Start date:
November 01, 2004
Estimated Completion Date:
November 30, 2005

Study Description

Parkinson's disease (PD) is a progressive motor disease characterized by bradykinesia or akinesia, rigidity, and resting tremor. Levodopa is still the most widely used treatment for PD, but as the disease progresses the drug tends to become less helpful. This is because of the development of motor response complications such as end-of-dose deterioration or wearing-off, peak dose dyskinesias, and ON-OFF phenomenon.

Comparison(s): The safety of 40 mg/d istradefylline and the efficacy for reducing the percentage of OFF time in patients with advanced PD treated with levodopa will be compared to placebo. The safety and efficacy of Entacapone will also be compared to placebo.

Connect with a study center

  • Kyowa Hakko UK Ltd.

    Slough, Berkshire SL14 DX
    United Kingdom

    Site Not Available

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