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

This study has been completed.
Information provided by:
Teva Pharmaceutical Industries Identifier:
First received: September 13, 2005
Last updated: April 8, 2011
Last verified: April 2011
This study is to determine if Tyramine has any side effects on patients receiving 0.5mg, 1mg of Rasagiline or Placebo

Condition Intervention Phase
Parkinson's Disease Drug: rasagiline mesylate Other: tyramine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Sub-study to Evaluate the Effect of An Oral Dose of Tyramine in Subjects Completing 26 Weeks of Participation in PRESTO (TVP-1012/133)

Resource links provided by NLM:

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • 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 ]

Enrollment: 55
Study Start Date: October 2000
Study Completion Date: January 2003
Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: rasagiline mesylate
    0.5 or 1 mg oral, once-daily
    Other Name: TVP-1012
    Other: tyramine
    50 mg once daily

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
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Please refer to this study by its identifier: NCT00203125

Sponsors and Collaborators
Teva Pharmaceutical Industries
Study Director: Phyllis Salzman, Ph.D. Teva Neuroscience, Inc.
  More Information

Responsible Party: J. Michael Nicholas, Sr. Director, US Regulatory Affairs, Teva Neuroscience Identifier: NCT00203125     History of Changes
Other Study ID Numbers: TVP - 1012/133a
Study First Received: September 13, 2005
Last Updated: April 8, 2011

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Adrenergic Agents
Neurotransmitter Agents processed this record on September 20, 2017