Status:

COMPLETED

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

Lead Sponsor:

Teva Branded Pharmaceutical Products R&D, Inc.

Conditions:

Parkinson's Disease

Eligibility:

All Genders

Phase:

PHASE3

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

October 1 2000

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2003

Estimated Enrollment :

55 Patients enrolled

Trial Details

Trial ID

NCT00203125

Start Date

October 1 2000

End Date

January 1 2003

Last Update

April 12 2011

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