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Long-Term Safety Study of KW-6002 (Istradefylline) in Parkinson's Disease Patients (6002-010)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00957203
Recruitment Status : Completed
First Posted : August 12, 2009
Last Update Posted : August 31, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
Patients with Parkinson's disease who completed the prior double-blind study 6002-009 are eligible to enter into this long-term study. The purpose of this study is to evaluate the safety and efficacy of KW-6002 administered long-term in patients with advanced Parkinson's disease treated with levodopa.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Istradefylline Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 308 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-Term Safety Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 3)
Study Start Date : October 2009
Primary Completion Date : September 2011
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Istradefylline Drug: Istradefylline
Oral istradefylline (KW-6002) 20 or 40 mg once daily
Other Name: KW-6002

Outcome Measures

Primary Outcome Measures :
  1. Adverse events

Secondary Outcome Measures :
  1. Reducing the mean total hours of awake time per day spent in the OFF state
  2. Reducing the mean percentage of awake time per day spent in the OFF state
  3. Mean change in the total hours and the percentage of awake time per day spent in the ON state (without dyskinesia, with dyskinesia, with non-troublesome dyskinesia, and with troublesome dyskinesia)
  4. Change in Unified Parkinson's Disease Rating Scale (UPDRS)
  5. Change in the Clinical Global Impression - Improvement scale (CGI-I)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Be willing and able to give written informed consent
  2. Completion of the study 6002-009

Exclusion Criteria:

  1. Mini-mental status examination score of 23 or less
  2. Less than 70% of compliance in the study 6002-009
  3. Emergency deviation in the study 6002-009
  4. Pregnant females
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00957203

Tokyo, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Co., Ltd
Study Director: Study Director Kyowa Hakko Kirin Co., Ltd
More Information

Responsible Party: Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier: NCT00957203     History of Changes
Other Study ID Numbers: 6002-010
First Posted: August 12, 2009    Key Record Dates
Last Update Posted: August 31, 2012
Last Verified: August 2012

Keywords provided by Kyowa Hakko Kirin Co., Ltd:
Parkinson's disease
end of dose wearing off
OFF time

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Adenosine A2 Receptor Antagonists
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs