PHASE II, DOUBLE-BLIND, DOSE-SEARCHED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SCH 420814 AS ADJUVANT THERAPY TO L-DOPA / DESPABOXYLASE DOPA INHIBITOR IN SUBJECTS WITH PARKINSON´S DISEASE.

Not Applicable

Completed

• Conditions: -G20 Parkinson´s disease; Parkinson´s disease; G20

• Registration Number: PER-091-03
• Lead Sponsor: SCHERING PLOUGH RESEARCH INSTITUTE,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12-31
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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 Subjects who have a dopamine agonist should have this medication withdrawn gradually before randomization.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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified