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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
78
novel levodopa/carbidopa formulation or a reference levodopa/carbidopa formulation
Fundacion Alfredo Thomson
Buenos Aires, Argentina
Hospital Posadas
Buenos Aires, Argentina
Hospital Ramos Mejía
Buenos Aires, Argentina
Hospital Sirio Libanés
Buenos Aires, Argentina
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
Time frame: every half hour for the first 8 hours after dosing
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)
Time frame: over the course of the study
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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