None listed
Conditions
Interventions
PNU-95666E Type of group
PNU-95666E will be administered in tablets, the dose will be increased in 7-day intervals, at a rate of 1, 2, 4, 8, 16, 24, 32 and 48 mg / day, until the Maintenance Phase: It could be any of Increase levels of doses. Gradual Reduction: The same doses as for the Increase Phase, in reverse order, with 1 day in each level.
Sponsors
PFIZER S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: Idiopathic Parkinson´s disease Modified Hoehn and Yahr Scale Stages 1-4 Age over 30 years Previous participation in prior sumanirole studies
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:measuring labs, ECG monitoring, vital signs and adverse events Measure:The long term safety and tolerability of sumanirole by measuring Safety labs, ECG monitoring, vital signs and adverse events, over a period of up to 4 years. Timepoints:a period of up to 4 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Three quality of life instruments will be used: a general scale: the functional status questionnaire, a specific scale of the disease, the Parkinsons disease questionnaire and a utility scale, the EuroQol. Measure:quality of life Timepoints:during 4 years | — |
Countries
Argentina, Colombia, Peru, Puerto Rico
Outcome results
None listed