A Phase 3 interventional study of rasagiline mesylate and tyramine in Parkinson's Disease, sponsored by Teva Branded Pharmaceutical Products R&D, Inc.. Completed. Per ClinicalTrials.gov, last updated 2011-04-12.
Sponsored by Teva Branded Pharmaceutical Products R&D, Inc. · Phase 3, Interventional, and Treatment
This study is to determine if Tyramine has any side effects on patients receiving 0.5mg, 1mg of Rasagiline or Placebo
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 55 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Teva Branded Pharmaceutical Products R&D, Inc. is the lead sponsor of 205 studies on the registry; none are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 47 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
0.5 or 1 mg oral, once-daily
Also known as: TVP-1012
50 mg once daily
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
No study locations are listed for this record.
This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.
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Teva Branded Pharmaceutical Products R&D, Inc.