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A Study to evaluate the add-on efficacy and safety of opicapone 50 mg or an extra dose of L-DOPA 100 mg for the treatment of wearing-off in patients with PD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opicapone 50mg | Experimental |
| |
| Levodopa 100mg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ongentys 50mg | Drug | Opicapone 50mg will be added to current and stable therapy of L-DOPA/DDCI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hauser's diary | Change in absolute OFF-time and ON-time. Since this study is exploratory, there is no separate primary endpoint. | Baseline, at 2 weeks, and 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Sacred Heart Hospital | Anyang-si | Gyeonggi-do | South Korea |
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| Madopar Tab. 125 or Perkin Tab. 25-100mg | Drug | Madopar Tab. 125 or Perkin Tab. 25-100mg will be added to current and stable therapy of L-DOPA/DDCI |
|
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| C549349 | opicapone |
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