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

Teva Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Parkinson's Disease

Treatments: Drug: rasagiline mesylate; Other: tyramine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00203125

TVP - 1012/133a

Details and patient eligibility

About

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

Enrollment: 55 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind