NCT00203125

Brief Summary

This study is to determine if Tyramine has any side effects on patients receiving 0.5mg, 1mg of Rasagiline or Placebo

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2000

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

April 12, 2011

Status Verified

April 1, 2011

Enrollment Period

2.3 years

First QC Date

September 13, 2005

Last Update Submit

April 8, 2011

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

rasagiline mesylateDRUG

0.5 or 1 mg oral, once-daily

Also known as: TVP-1012
tyramineOTHER

50 mg once daily

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must provide separate informed consent to participate in the Tyramine Sub-Study.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson Disease

Interventions

rasagilineTyramine

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Biogenic MonoaminesBiogenic AminesAminesOrganic Chemicals

Study Officials

  • Phyllis Salzman, Ph.D.

    Teva Neuroscience, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

October 1, 2000

Primary Completion

January 1, 2003

Study Completion

January 1, 2003

Last Updated

April 12, 2011

Record last verified: 2011-04