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

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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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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