Estudio de fase III, doble ciego, controlado con placebo, de dosis-respuesta fija, que compara la eficacia y seguridad de sumanirole versus placebo en pacientes con enfermedad de Parkinson temprana

CompletadoFase 3ClinicalTrials.gov

ID: NCT00058838Tipo: INTERVENTIONALInicio: 1 de abr de 2003Fin estimado: 1 de sept de 2004

Resumen

El propósito principal de este estudio es determinar si sumanirole, en tres niveles de dosis diferentes, es eficaz y seguro en el tratamiento de los signos y síntomas de la enfermedad de Parkinson temprana.

Elegibilidad

Edad mínima: 30 YearsSexo: ALL

Criterios de inclusión

Idiopathic Parkinson's disease \< 7 years duration
Modified Hoehn and Yahr Scale Stages I through III
Age greater than or equal to 30 years old
Patients or their partners must use adequate contraceptive methods
Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures and do not plan on traveling extensively during the study

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

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