A Study to Evaluate the Effects of Tyramine in Patients Who Completed the PRESTO Study.
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
rasagiline mesylate
tyramine
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease
Eligibility 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.
Sites / Locations
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00203125
First Posted
September 13, 2005
Last Updated
April 8, 2011
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00203125
Brief Title
A Study to Evaluate the Effects of Tyramine in Patients Who Completed the PRESTO Study.
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)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
January 2003 (Actual)
Study Completion Date
January 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is to determine if Tyramine has any side effects on patients receiving 0.5mg, 1mg of Rasagiline or Placebo
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
rasagiline mesylate
Other Intervention Name(s)
TVP-1012
Intervention Description
0.5 or 1 mg oral, once-daily
Intervention Type
Other
Intervention Name(s)
tyramine
Intervention Description
50 mg once daily
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phyllis Salzman, Ph.D.
Organizational Affiliation
Teva Neuroscience, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Effects of Tyramine in Patients Who Completed the PRESTO Study.
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