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

This study has been completed.
Sponsor:
Information provided by:
Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT00199433
First received: September 12, 2005
Last updated: June 22, 2010
Last verified: February 2007

September 12, 2005
June 22, 2010
May 2005
Not Provided
Change from baseline in the UPDRS subscale III at endpoint.
Same as current
Complete list of historical versions of study NCT00199433 on ClinicalTrials.gov 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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
August 2006
Not Provided

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
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00199433
6002-US-051
No
Not Provided
Kyowa Hakko Kirin Pharma, Inc.
Not Provided
Study Director: Neil Sussman, MD Kyowa Hakko Kirin Pharma, Inc.
Kyowa Hakko Kirin Pharma, Inc.
February 2007

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