A Study to Evaluate the Effects of Tyramine in Patients Who Completed the PRESTO Study.

Phase 3CompletedNCT00203125

Teva Branded Pharmaceutical Products R&D, Inc.55 enrolled

Overview

This study is to determine if Tyramine has any side effects on patients receiving 0.5mg, 1mg of Rasagiline or Placebo

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Parkinson's Disease

Interventions

rasagiline mesylateDRUG

0.5 or 1 mg oral, once-daily

tyramineOTHER

50 mg once daily

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: Men and women with idiopathic Parkinson's disease (PD) who have met inclusion criteria for PRESTO, and have completed the 26-week PRESTO study. The subject should be available to participate in the sub-study immediately following the last PRESTO visit (same day). Subjects must continue PRESTO study drug until the morning of the Tyramine Sub-Study. Subjects must provide separate informed consent to participate in the Tyramine Sub-Study. Exclusion Criteria: Subjects must not have a history of intracranial aneurysm or stroke. Subjects should not have uncontrolled hypertension, defined as systolic pressure \> 160 mmHg, or diastolic pressure \> 90 mmHg.

Outcomes

Primary Outcomes

An increase in systolic blood pressure of > 30mmHg from the mean baseline value (documented by at least 3 consecutive measurements). Or Bradycardia with a heart rate below 40 beats per minute

Time frame: 26 weeks

Data from ClinicalTrials.gov

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