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| Name | Class |
|---|---|
| Kyowa Kirin Co., Ltd. | INDUSTRY |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Istradefylline (KW-6002) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the UPDRS subscale III at endpoint. |
| 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: | ||
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neil Sussman, MD | Kyowa Kirin, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyowa Pharmaceutical Inc. | Princeton | New Jersey | 08540 | United States |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D009069 | Movement Disorders |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C111599 | istradefylline |
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| Exam |
| vitals |
| weight |
| ECG |
| laboratory tests and adverse events |
| D009422 | Nervous System Diseases |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |