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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-005861-21 | EudraCT Number |
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The purpose of this study is to determine the long-term efficacy and safety of two doses of safinamide (50 and 100 mg/day, p.o), compared to placebo, as add-on therapy in patients with idiopathic Parkinson's disease with motor fluctuations, who are currently receiving a stable dose of levodopa.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose (50mg/day) | Experimental |
| |
| High Dose (100mg/day) | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Safinamide | Drug |
| ||
| Safinamide |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in the dyskinesias rating scale (DRS) during "on" time | mean change in the dyskinesias rating scale (DRS) during "on" time from baseline (study 016) to endpoint (last visit in study 018). | Up to 104 weeks (from baseline 016 to EOS study 018) |
| Measure | Description | Time Frame |
|---|---|---|
| Endpoints include 'ON time', responder rates and UPDRS IV change |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| See Study 016 for details | PI's are the same as for study NW-1015/016/III/2006 | Principal Investigator |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 24, 2016 | |
| Reset | Jul 1, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 24, 2016 | Jul 1, 2016 |
| 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 |
|---|---|
| C092797 | safinamide |
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|
| Placebo | Drug |
|
| Up to 104 weeks (from baseline 016 to EOS study 018) |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |