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The sponsor decided to postpone the performance of this study to after phase 3
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An extension of study IN 09 004 testing the long term safety of the Accordion Pill Carbidopa/Levodopa (AP-CD/LD)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extension | Experimental | Open label extension, 1 arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AP-CD/LD | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess patient and investigator global evaluation of, and degree of satisfaction with, AP-CD/LD (CGI, GSS) |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life questionnaires | ||
| Daytime sleepiness | ||
| Efficacy measures of motor symptoms |
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Inclusion Criteria:
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Medical Center | Haifa | Israel | ||||
| Wolfson Medical Center |
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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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| Holon |
| Israel |
| Rabin Medical Center | Petah Tikva | Israel |
| Sheba Medical Center | Ramat Gan | Israel |
| TASMC | Tel Aviv | Israel |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |