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A Study of Istradefylline (KW-6002) as Monotherapy in Parkinson's Disease (PD) Patients

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. Identifier: NCT00199433
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : July 13, 2016
Information provided by:
Kyowa Kirin Pharmaceutical Development, Inc.

Brief Summary:
The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of 40 mg per day of istradefylline (KW6002) as monotherapy in patients with Parkinson's disease.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Movement Disorder Syndrome Drug: Istradefylline (KW-6002) Phase 2

Detailed Description:

Parkinson's disease is a progressive disease which results in deterioration of motor function and is the result of dopamine depletion in specific brain structures. Current therapeutic approaches include dopamine replacement and the use of dopamine receptor agonist drugs. These therapies are effective but may be associated with unwanted complications like wearing off phenomena and involuntary abnormal movements (dyskinesia). Istradefylline may provide a nondopaminergic approach to the treatment of Parkinson's disease.

This study will compare the efficacy of 40 mg per day of istradefylline in improving the symptoms of Parkinson's disease with placebo.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase 2, Double-blind, Placebo-controlled, Randomized, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of 40mg/Day KW-6002 (Istradefylline) as Monotherapy in Subjects With Parkinson's Disease
Study Start Date : May 2005
Primary Completion Date : July 2006
Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Change from baseline in the UPDRS subscale III at endpoint.

Secondary Outcome Measures :
  1. Interim actual and change from baseline values in UPDRS total and subscale scores, Clinical Global Impression, measures of motor performance, and neuropsychological testing.
  2. Safety:
  3. Exam
  4. vitals
  5. weight
  6. ECG
  7. laboratory tests and adverse events

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Early PD by UKPDS criteria
  2. Mild to moderate difficulty daily activities
  3. Females: Either postmenopausal or willing to use adequate contraception

Exclusion Criteria:

  1. Unable to discontinue current PD medication
  2. Exposure to Levodopa for more than 1 month
  3. Symptoms that may suggest a diagnosis other than Parkinson's disease
  4. Medical conditions and/or abnormal laboratory findings which preclude participation including cancer in the last 5 years, a history of drug abuse/dependence, abnormal cognitive status, a history of seizures, neuroleptic malignant syndrome, psychosis, or abnormal liver function tests

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 identifier (NCT number): NCT00199433

United States, New Jersey
Kyowa Pharmaceutical Inc.
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
Kyowa Kirin Pharmaceutical Development, Inc.
Study Director: Neil Sussman, MD Kyowa Kirin Pharmaceutical Development, Inc. Identifier: NCT00199433     History of Changes
Other Study ID Numbers: 6002-US-051
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2016

Keywords provided by Kyowa Kirin Pharmaceutical Development, Inc.:
Parkinson's Disease
Movement Disorder
Clinical Trial

Additional relevant MeSH terms:
Parkinson Disease
Movement Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
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