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To establish the efficacy of 40 mg/day doses of istradefylline for the change in Unified Parkinson's Disease Rating Scale (UPDRS) part-III (Motor examination) score in patients with Parkinson's disease (PD).
To establish the efficacy of 40mg/d doses of istradefylline for the change in UPDRS part-III (Motor examination) score in patients with Parkinson's disease (PD). Patients who meet entry criteria will be randomly assigned to receive study drug in 1 of 2 arms: Condition A (doses of 40mg/d istradefylline) in Period 1 followed by Condition B (matching placebo) in Period 2 (putting 4 weeks interval phase between two periods ) or Condition B in Period 1 followed by Condition A in Period 2(putting 4 weeks interval phase between two periods ). Patients will be participated for 12 weeks and will have interim visits and end of treatment visit to assess the efficacy and safety of istradefylline.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Istradefylline (KW-6002) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To establish the efficacy of 40mg/d doses of istradefylline for the change in UPDRS part-III (Motor examination) score in patients with Parkinson's disease (PD). |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy of 40mg/d dose of istradefylline for the change in UPDRS part-I (Mentation, behavior and mood), part-II (Activities of daily living) score and UPDRS total (parts I-III) score. | ||
| To evaluate change in the Clinical Global Impression - Improvement scale (CGI-I). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Kyowa Kirin Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo | Japan |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| 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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| To evaluate change in the Clinical Global Impression - Severity of Illness scale (CGI-S). |
| To evaluate the safety of 40mg/d doses of istradefylline. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |