None listed
Conditions
Interventions
Sumanirole 4mg Type of group
The treatment consists of 5 weeks of increase, 26 weeks of maintenance, followed by 1 week of decrease.
Group name:Sumarinole 16 mg Type of group
The treatment consists of 5 weeks of increase, 26 weeks of maintenance, followed by 1 week of decrease.
Sponsors
PHARMACIA & UPJOHN INTERAMERICAN CORPORATION SUCURSAL DEL PERU,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Idiopathic Parkinson´s disease 30 years. 4. Patients or their partners should use adequate contraception. 5. Evidence of a personally signed informed consent document and dated indicating that the patient (or a legally acceptable representative) has been informed of all the aspects related to the study. 6. Patients who are willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures and who do not plan to travel extensively during the study.
Exclusion criteria
Exclusion criteria: 1. Parkinson´s disease syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases. 2. Have received L-dopa for an accumulated interval of> 1 year in the previous 2 years. 3. Have received L-dopa, dopamine agonist drugs (eg pramipexole), catacol-o-methyl transferase (COMT) inhibitors, (eg entacapon) within 30 days prior to basal, (allowed: selegiline, therapy anticholinergic or with amantidine at a stable dose for 30 days before the study and during the study). 4. History of stereotactic brain surgery. 5. Hepatitis B (superlicity antigen) or hepatitis (J (antibody) positive. 6. Surgery within 180 days of the baseline visit, which, in the opinion of the investigator, would have a negative impact on the patient´s participation in the study. 7. Dementia (score on the Mini-Mental Exam <24). 8. History of active epilepsy (ie, presence of a seizure) during the last year. 9. Third-degree AV block or sick node syndrome. 10. Congestive heart failure classified as Class N or IV by the New York Heart Association. 11. Myocardial infarction in the 6 months prior to baseline.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Unified Parkinson s Disease Rating Scale Measure:Change from baseline in UPDRS (Unified Parkinson s Disease Rating Scale) II + III total scores at end of maintenance, for sumanirole compared to placebo Timepoints:31 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:quality of life Measure:To assess the safety profile of sumanirole and the benefit of sumanirole in quality of life measures compared to placebo. Timepoints:31 week | — |
Countries
Argentina, Australia, Belgium, Colombia, France, Germany, Greece, Ireland, Italy, Mexico, Peru, Spain
Outcome results
None listed