A Study of Istradefylline (KW-6002) as Monotherapy in Parkinson's Disease (PD) Patients
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.
Movement Disorder Syndrome
Drug: Istradefylline (KW-6002)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
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|
- Change from baseline in the UPDRS subscale III at endpoint.
- Interim actual and change from baseline values in UPDRS total and subscale scores, Clinical Global Impression, measures of motor performance, and neuropsychological testing.
- laboratory tests and adverse events
|Study Start Date:||May 2005|
|Estimated Study Completion Date:||August 2006|
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.
|United States, New Jersey|
|Kyowa Pharmaceutical Inc.|
|Princeton, New Jersey, United States, 08540|
|Study Director:||Neil Sussman, MD||Kyowa Hakko Kirin Pharma, Inc.|