Open-Label, Long Term, Flexible Dose Study Of Safety, Tol... | EligiMed

Open-Label, Long Term, Flexible Dose Study Of Safety, Tolerability, And Therapeutic Response In Patients With Parkinson's Disease.

TerminadoFase 3ClinicalTrials.gov

ID: NCT00036205Tipo: INTERVENTIONALInicio: 1 de ago de 2000Fin estimado: 1 de dic de 2004

Traducción no disponible, mostrando original

Resumen

The primary objective is to assess the long term safety and tolerability of sumanirole as measured by safety labs, ECG monitoring, vital signs, and adverse event reports in subjects with Parkinson's Disease who participated in previous sumanirole studies.

Elegibilidad

Edad mínima: 30 YearsSexo: ALL

Criterios de inclusión

Idiopathic Parkinson's disease
Modified Hoehn and Yahr Scale Stages 1-4
Age over 30 years
Previous participation in prior sumanirole studies

Criterios de exclusión

Use of dopamine agonist medications and other medications in defined timeframe
Unstable dose of CNS active therapies (eg, hypnotics, antidepressants, anxiolytics) within the last 30 days
Atypical Parkinson's syndromes due to drugs, metabolic disorders, encephalitis, or degenerative diseases
Dementia
History of active epilepsy within the past year
Significant liver disease with defined laboratory criteria
Significant renal disease with defined laboratory criteria
Certain cardiac conditions
Electroconvulsive therapy in the previous 90 days
Subjects participating in other drug studies or receiving other investigational drugs within previous 30 days
Positive pregnancy test at Screen
Unwillingness to use adequate contraceptive methods
Lactating women
History of stereotaxic brain surgery
Malignant melanoma or history of treated melanoma

Intervenciones

drug

sumanirole

Ubicaciones

Pfizer Investigational Site

Buenos Aires, Barcelona, 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

Patrocinadores

PrincipalPfizer

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