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Determine if a novel levodopa/carbidopa formulation results in a better clinical response on Parkinson's Disease patients compared to the reference formulation of levodopa/carbidopa in terms of motor complications, onset of action and response duration.
Primary objective is to demonstrate a better clinical response profile of novel levodopa/carbidopa formulation vs. the reference formulation of levodopa/carbidopa in patients with Parkinson's Disease as judged by motor performance and to describe pharmacokinetic profile for the novel formulation compared to the reference.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator |
| |
| B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levodopa-carbidopa | Drug | novel levodopa/carbidopa formulation or a reference levodopa/carbidopa formulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evidence of a novel levodopa/carbidopa formulation providing a better clinical profile than reference levodopa/carbidopa formulation using Unified Parkinson's Disease Rating Scale (UPDRS III) and patient's diary cards | every half hour for the first 8 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Other measurements to be used for demonstrating clinical profile is UPDRS II and IV, Clinical Global Impression Scale (CGI)/Patient's Global Improvement Scale (PGI), and the Abnormal Involuntary Movement Scale (AIMS) | over the course of the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gustavo Fischbein, M.D. | Osmotica Pharmaceutical Argentina S.A. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundacion Alfredo Thomson | Buenos Aires | Argentina | ||||
| Hospital Posadas |
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| Buenos Aires |
| Argentina |
| Hospital Ramos Mejía | Buenos Aires | Argentina |
| Hospital Sirio Libanés | Buenos Aires | Argentina |
| Instituto Frenopático | Buenos Aires | Argentina |
| nstituto INEBA | Buenos Aires | Argentina |
| Policlínica Bancaria | Buenos Aires | Argentina |
| Fundación Rosarina de Neuro-Rehabilitación | Rosario | Argentina |
| Hospital San Bernardo | Salta | Argentina |
| 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 |
|---|---|
| C009265 | carbidopa, levodopa drug combination |
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