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

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00203125
First received: September 13, 2005
Last updated: April 8, 2011
Last verified: April 2011
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00203125

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

No publications provided

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

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Tyramine
Rasagiline
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Neuroprotective Agents
Protective Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013