A Phase III, Double-Blind, Placebo-Controlled, Randomized Study Comparing the Efficacy, Safety, and Tolerability of Sumanirole Versus Placebo or Ropinirole in Patients With Early Parkinson's Disease.

CompletadoFase 3ClinicalTrials.gov

ID: NCT00036218Tipo: INTERVENTIONALInicio: 1 de dic de 2001Fin estimado: 1 de abr de 2003

Traducción no disponible, mostrando original

Resumen

The primary purpose of this study is to determine whether sumanirole is effective and safe in the treatment of the signs and symptoms of early Parkinson's disease.

Elegibilidad

Edad mínima: 30 YearsSexo: ALL

Criterios de inclusión

Parkinson's disease of less than 7 years duration
Modified Hoehn and Yahr Scale Stages 1 through 3.
Age greater than or equal to 30 years old.
Men or women (women of childbearing potential must have a negative pregnancy test at screen) and both must use adequate contraceptive methods.
Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Criterios de exclusión

Atypical Parkinson's disease syndromes due to drugs, metabolic disorders, encephalitis, or degenerative diseases.
Levodopa received for 1-year accumulated interval in the last two years.
Dopamine agonist medications or catechol-o-methyl transferase inhibitors in the 30 days prior to baseline.
Unstable dose regimes of hypnotics, anxiolytics or antidepressants
Dementia
History of stereotaxic brain surgery, psychosis or active epilepsy within past year.
Participation in clinical trial within the previous 30 days.
Malignant melanoma or history of melanoma
Significant medical or pshychiatric condition.

Intervenciones

drug

sumanirole

drug

ropinirole

Ubicaciones

Pfizer Investigational Site

Buenos Aires, Buenos Aires, Argentina

Pfizer Investigational Site

Buenos Aires, Buenos Aires, Argentina

Pfizer Investigational Site

Buenos Aires, Buenos Aires, Argentina

Pfizer Investigational Site

Mar del Plata, Buenos Aires, Argentina

Pfizer Investigational Site

Buenos Aires, Buenos Aires F.D., Argentina

Pfizer Investigational Site

Buenos Aires, Buenos Aires F.D., Argentina

Patrocinadores

PrincipalPfizer

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