A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease
A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease
The purpose of this study is to evaluate the efficacy of 40 mg a day of istradefylline
 (KW-6002) for reducing the percentage of awake time spent in the OFF state in patients with
 advanced Parkinson's disease treated with levodopa.
Parkinson's disease (PD) is a progressive motor disease characterized by bradykinesia or
 akinesia, rigidity, and resting tremor. Levodopa is still the most widely used treatment for
 PD, but as the disease progresses the drug tends to become less helpful. This is because of
 the development of motor response complications such as end-of-dose deterioration or
 wearing-off, peak dose dyskinesias, and ON-OFF phenomenon.

 Comparison(s): The safety of 40 mg/d istradefylline and the efficacy for reducing the
 percentage of OFF time in patients with advanced PD treated with levodopa will be compared to
 placebo. The safety and efficacy of Entacapone will also be compared to placebo.
Inclusion Criteria:

 Patients selected for this study will be at least 30 years of age and will have been
 diagnosed with advanced Parkinson's disease as determined by UK Parkinson's Disease Society
 (UKPDS) criteria and the Modified Hoehn and Yahr Scale. The patients will have been
 receiving levodopa treatment for at least one year, may be taking other antiparkinsonian
 drugs, will have an average of at least three hours OFF time as recorded in two 24-hour
 ON/OFF diaries, and if female, must be non-pregnant and non-nursing.

 Exclusion Criteria:

 Patients may not be enrolled if they are taking certain medications excluded by the
 protocol, have been treated with any investigational drug within 30 days prior to
 randomisation (or five half-lives if longer), have ever received istradefylline or been
 treated with a COMT inhibitor, are psychotic, have clinically significant illness or
 laboratory values at screening, have insufficient mental capacity to comply with protocol
 requirements or certain psychiatric or neurological conditions.

 -