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

NCT ID: NCT00203125

Last Updated: 2011-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-10-31

Study Completion Date

2003-01-31

Brief Summary

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

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Detailed Description

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Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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rasagiline mesylate

0.5 or 1 mg oral, once-daily

Intervention Type DRUG

tyramine

50 mg once daily

Intervention Type OTHER

Other Intervention Names

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TVP-1012

Eligibility Criteria

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Inclusion Criteria

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Teva Neuroscience

Principal Investigators

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Phyllis Salzman, Ph.D.

Role: STUDY_DIRECTOR

Teva Neuroscience, Inc.

Other Identifiers

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TVP - 1012/133a

Identifier Type: -

Identifier Source: org_study_id

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