Parkinson's Disease
Conditions
Brief summary
This study is to determine if Tyramine has any side effects on patients receiving 0.5mg, 1mg of Rasagiline or Placebo
Interventions
0.5 or 1 mg oral, once-daily
OTHERtyramine
50 mg once daily
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 26 weeks |
Outcome results
None listed