A Study of Istradefylline (KW-6002) as Monotherapy in Parkinson's Disease (PD) Patients
|ClinicalTrials.gov Identifier: NCT00199433|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : July 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease Movement Disorder Syndrome||Drug: Istradefylline (KW-6002)||Phase 2|
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|
|Intervention Model:||Parallel Assignment|
|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|
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00199433
|United States, New Jersey|
|Kyowa Pharmaceutical Inc.|
|Princeton, New Jersey, United States, 08540|
|Study Director:||Neil Sussman, MD||Kyowa Kirin Pharmaceutical Development, Inc.|