Resumen

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.

Descripción detallada

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.

Elegibilidad

Edad mínima: 30 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Clinical diagnostic of Parkinson's Disease, with a Hoehn and Yahr Staging within 2-4, and L-Dopa therapy complications
at least 2years of L-Dopa therapy
Patients with the ability to differentiate between "ON" and "OFF" periods
Patients who have been receiving stable doses of L-Dopa between 600 and 1600 mg/day, for at least 2 months prior to the screening visit using a dosing regimen not higher that 5 times a day, and not expected in the investigator's opinion to need any dose modifications over the duration of the study
Patients presenting a score of at least 2 in the UPDRS IVa, item 32 and/or a score of at least 2 in the UPDRS IVb, item 39, at screening and randomization visits based on clinical records for the first visit and daily diary cards at randomization time.
Willing and able to understand and sign Informed Consent form

Criterios de exclusión

Patients with a diagnosis of any known secondary Parkinsonian syndrome, (vascular, toxin or drug-induced, metabolic or infectious, etc) or other neurodegenerative disorder with parkinsonism (Progressive Supranuclear Palsy, Corticobasal Degeneration, Multiple System Atrophy, etc).
Patients receiving other concomitant anti-Parkinsonian pharmacological therapies affecting L-dopa or dopamine metabolisom (COMT inhibitors or MAO inhibitors)
Subjects who have undergone prior functional neurosurgical treatment for PD (ablation or Deep Brain Stimulation).
Patient with a L-dopa dosage regimen greater than 5 times a day which is not able to be adapted to a q.i.d. regimen.
Patients having received L-dopa / Decarboxylase inhibitors therapy for less than 2 years.
Patients needing nightly doses of L-dopa / Decarboxylase inhibitors apart from the four daily doses.
Any medical condition or past medical history that, in the investigator's judgment, would increase the risk of exposure to L-dopa / Carbidopa or interfere with the evaluation of the study objectives.
Patients with unstable or clinically significant known medical illness; such as cardiac, pulmonary, kidney, hepatic and/or gastrointestinal disease that would, in the investigator's judgment, interfere with the safe course of the study.
Cognitive impaired patients, as determined by a score of lesser than 26 on the Mini-Mental Score Status Examination. (MMSE \< 26).
Alcohol or illegal drugs abuse.
Pregnant or lactating patients.
Hypersensitivity to any of the investigational drugs, based on known allergies to drugs of the same class.
Patients having taken any research drugs over the last 30 days prior to the beginning of the study.
Blood donation, or blood products, or participation to a clinical trial with serial blood withdrawals, within twelve weeks prior to the start of the trial, or intention to donate blood or blood products within three months following the study completion.
Patients who have received some of the following medications with an anticipation of no more than 7 treatment-drug elimination half-lives of entry time: Dopamine D2 receptor antagonists , isoniazid, anti-epileptic drugs, IMAO A or B, pyridoxine, ferrous salts or methyldopa.

Ubicaciones

Fundacion Alfredo Thomson

Buenos Aires, Argentina

Hospital Posadas

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

An Efficacy, Safety, and Pharmacokinetics/Pharmacodynamic Relationship Study of L-Dopa/Carbidopa in a Novel Release Formulation in Parkinson's Disease Patients

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

levodopa-carbidopa

Ubicaciones

Fundacion Alfredo Thomson

Hospital Posadas

Hospital Ramos Mejía

Hospital Sirio Libanés

Instituto Frenopático

nstituto INEBA

Policlínica Bancaria

Fundación Rosarina de Neuro-Rehabilitación

Hospital San Bernardo

Patrocinadores