STUDY PHASE 2, DOUBLE-BLIND, DOSE SEARCH, CONTROLLED WITH PLACEBO TO EVALUATE THE SAFETY AND EFFICACY OF SCH 420814 AS A MONOTHERAPY IN SUBJECTS WITH EARLY PARKINSON DISEASE.

Phase 1

• Registration Number: PER-037-03
• Lead Sponsor: SCHERING PLOUGH RESEARCH INSTITUTE,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2003-07-31
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

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

Inclusion Criteria

1. The subjects must be at least 30 years old, they can be both
sexes and of any race.
2. Must have a diagnosis of mild idiopathic Parkinson´s disease
according to what is defined by the Hoehn and Yahr criteria.
3. Women should not be able to conceive.
4. They must be candidates for symptomatic therapy.
5. Subjects may have received a dopamine or L-dopa agonist as
monotherapy for no more than 6 months before selection.
6. Subjects receiving a dopamine or L-dopa agonist should relize
gradually of said medication before randomization.
7. Those who receive selegiline, amantadine, coenzyme Q10 and / or anticholinergics must remain on a stable regimen for at least 4 weeks before of the selection. The subjects must stay in the stable regime throughout the study.

Exclusion Criteria

1. Subjects who have any form of atypical parkinsonism or drug induced.
2. Subjects with any form of dementia (score <23 minimental examination).
3. Subjects with a history of major depressive episode, or unstable mild depression or psychosis diagnosed by the DSM IV. Subjects with mild depression who are well controlled with stable doses of antidepressant medication for at least 4 weeks before screening will meet the eligibility criteria.
4. Subjects with a severe or unstable medical condition in progress.
5. Subjects with a cerebrovascular history, hypertension, and / or any form of clinically significant heart disease.
6. Subjects with a history of symptomatic orthostatic hypotension defined as the presence of symptoms in the standing position or a fall in the systolic BP of> 20 mm Hg after 2 minutes.
7. Subjects with the following PS measurements at any time during the course of the study (confirmed by a second measurement).

Study & Design

• Study Type: Interventional
• Study Design: Not specified