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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Parkinson's Disease, Movement Disorder Syndrome

Intervention / Treatment
-----------------
* Drug: Istradefylline (KW-6002)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Early PD by UKPDS criteria Mild to moderate difficulty daily activities Females: Either postmenopausal or willing to use adequate contraception Exclusion Criteria: Unable to discontinue current PD medication Exposure to Levodopa for more than 1 month Symptoms that may suggest a diagnosis other than Parkinson's disease 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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Istradefylline (KW-6002)|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the UPDRS subscale III at endpoint. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's Disease, Movement Disorder, Neurology,, Clinical Trial