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Study to look at the effectiveness, tolerability and safety of two doses of Rasagiline (0.5 mg and 1mg) in advanced Parkinson's Disease (PD) Patients who have been treated with Levodopa/Carbidopa therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental 1 | Experimental | 0.5 mg rasagiline mesylate oral once daily |
|
| Expermental 2 | Experimental | 1.0 mg rasagiline mesylate oral once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rasagiline mesylate | Drug | 0.5 rasagiline mesylate |
| |
| rasagiline mesylate 1.0 mg |
| Measure | Description | Time Frame |
|---|---|---|
| long-term safety and tolerability of rasagiline | To evaluate the long-term safety and tolerability of rasagiline in PD patients with motor fluctuations treated with chronic levodopa/carbidopa (LD/CD) or levodopa/benserazide (LD/BZD) therapy. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| long- term clinical effect of rasagiline | To assess the long- term clinical effect of rasagiline on the course of the disease. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Phyllis Salzman, Ph.D. | Teva Neuroscience, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Margolin Brain Institute | Fresno | California | 93720 | United States | ||
| Emory University |
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| Drug |
1.0 mg rasagiline mesylate |
|
| Atlanta |
| Georgia |
| 30329 |
| United States |
| Rush - Presbyterian St. Luke's Medical Center | Chicago | Illinois | 60612 | United States |
| Creighton University | Omaha | Nebraska | 68131 | United States |
| Long Island Jewish Medical Center | New Hyde Park | New York | 11040 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Pennsylvania Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| CHUM-Hotel-Dieu | Montreal | Quebec | H2w1T8 | Canada |
| 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 |
|---|---|
| C031967 | rasagiline |
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