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.

September 12, 2005
September 20, 2005
July 13, 2016
May 2005
July 2006   (Final data collection date for primary outcome measure)
Change from baseline in the UPDRS subscale III at endpoint.
Same as current
Complete list of historical versions of study NCT00199433 on Archive Site
  • Interim actual and change from baseline values in UPDRS total and subscale scores, Clinical Global Impression, measures of motor performance, and neuropsychological testing.
  • Safety:
  • Exam
  • vitals
  • weight
  • ECG
  • laboratory tests and adverse events
Same as current
Not Provided
Not Provided
A Study of Istradefylline (KW-6002) as Monotherapy in Parkinson's Disease (PD) Patients
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
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.

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.

Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Parkinson's Disease
  • Movement Disorder Syndrome
Drug: Istradefylline (KW-6002)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
August 2006
July 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
30 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
Kyowa Kirin Pharmaceutical Development, Inc.
Not Provided
Study Director: Neil Sussman, MD Kyowa Kirin Pharmaceutical Development, Inc.
Kyowa Kirin Pharmaceutical Development, Inc.
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP