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The purpose of this study is to evaluate blood level profiles of multiple oral doses of AP09004 vs. active control and to determine its safety and efficacy in Parkinson's patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early patients | Experimental |
| |
| Moderate Patients | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AP09004 | Drug |
| ||
| Carbidopa/Levodopa, immediate release |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate blood level profiles and safety of the AP09004 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of AP09004 on motor scores in Parkinson's patients |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| T Gurevich, MD | Tel-Aviv Sourasky Medical Center | Principal Investigator |
| R. Djaldetti, Prof. MD | Rabin Medical Center | Principal Investigator |
| O. Cohen, MD | Sheba Medical Center | Principal Investigator |
| Ilana Schlesinger Schlesinger, MD | Rambam Health Care Campus, Haifa, Movement Disorders and Parkinson's Disease | Principal Investigator |
| Ron Milo, M.D | Barzilai Medical Center, Department of Neurology, Movement disorders unit, Ashkelon, Israel | Principal Investigator |
| Peter Farkas, M.D | Department of Neurology, Clalit University Medical Center | Principal Investigator |
| Marieta Anca-Herschkovitsch, M.D | Edith Wolfson , Dept. of Neurology, Movement Disorders Unit. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barzilai Medical Center, Department of Neurology, Movement disorders unit, | Ashkelon | Israel | ||||
| Department of Neurology, Clalit University 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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| ID | Term |
|---|---|
| C009265 | carbidopa, levodopa drug combination |
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| Drug |
|
| Beersheba |
| Israel |
| Rambam Health Care Campus, Haifa, Movement Disorders and Parkinson's Disease | Haifa | Israel |
| Edith Wolfson , Dept. of Neurology, Movement Disorders Unit. | 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 |