None listed
Conditions
Interventions
5 mg SCH 420814 Type of group
They will self-administer blind-type medication orally, twice a day (during waking hours, approximately 8 hours apart) for 12 weeks.
Group name:Placebo Type of group
They will self-administer blind-type medication orally, twice a day (during waking hours, approximately 8 hours apart) for 12 weeks.
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Inclusion criteria
Inclusion criteria: The subjects must be> 30 years of age, diagnosed with idiopathic Parkinson´s disease, Hoehn and Yahr stage of 2-4 in the off state, and be with a stable regimen of L-dopa + dopa decarboxylase inhibitor for 4 years. weeks before randomization. While they are with a stable dose of L-dopa, the subjects must manifest continuous motor fluctuations, which are defined as simple fluctuations on / off, dose-dependent, and / or akinesia by termination of the dose. The subjects must be able to recognize the on and off states and the dyskinesias and understand how to complete the journals with the help of an assistant, if necessary. In the start-up period, subjects must have a minimum off time of at least 2 hours per day for 3 consecutive days (excluding the morning period before the dose and the period after the dose until the medication is delivered). effect). Subjects who have a dopamine agonist should have this medication withdrawn gradually before randomization.
Exclusion criteria
Exclusion criteria: Subjects who submit any form of study will be excluded from the study. atypical or drug-induced parkinsonism, cognitive impairment (score <23 of the MMSE), a history of major depressive episode, or unstable mild depression or psychosis according to the DSM IV diagnosis. Subjects with complex motor fluctuations will be excluded. The Subjects with mild depression who are well controlled with stable doses of antidepressant medication for at least 4 weeks before randomization will meet the eligibility criteria. Subjects with a history of: hypertension, cerebrovascular disease, or any form of clinically significant heart disease, asymptomatic orthostatic hypotension, liver or kidney failure, seizures, alcohol or drug dependence, or previous surgery for Parkinson´s disease will be excluded. All subjects who have an unstable, severe or ongoing medical condition will be excluded. Women who can conceive will be excluded, regardless of the type of contraception they use.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The main efficacy objective is the average change with respect to the start in the 3-day average of the percentage of wakefulness spent in the off state, excluding the morning off period before and after the dose until the medication it takes effect. The final objective is taken from the latest data available in the subject diary of 3 days after the start during the double blind treatment period. Measure:Efficacy, safety and tolerability of SCH 420814 as adjuvant therapy to a stable regimen of L-Dopa / dopa decarboxylase inhibitor in subjects with idiopathic Parkinson disease (PD) not optimally controlled with L-Dopa. Timepoints:In weeks 2, 4, 6, 8, 10, and 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Average change from the beginning to the goal in the score of the UPDRS Measure:Evaluate the effect of SCH 420814 on the UPDRS Timepoints:In weeks 2, 4, 6, 8, 10, and 12. | — |
Countries
Peru
Outcome results
None listed