A Study to Evaluate the Effects of Tyramine in Patients W... | NCT00203125

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

NCT00203125

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Status

Completed

Last Update Posted

Apr 12, 2011Estimated

Enrollment

55Actual

Phase

Phase 3

Conditions

Parkinson's Disease

Interventions

rasagiline mesylate
tyramine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2000

Primary Completion Date

Jan 2003Actual

Completion Date

Jan 2003Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 8, 2011

Last Update Posted Date

Apr 12, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

55Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rasagiline mesylate	Drug	0.5 or 1 mg oral, once-daily		TVP-1012
tyramine	Other	50 mg once daily

Outcomes Module

Primary Outcomes

Measure	Description	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Phyllis Salzman, Ph.D.	Teva Neuroscience, Inc.	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C031967	rasagiline
D014439	Tyramine

Ancestor Terms

ID	Term
D015306	Biogenic Monoamines
D001679	Biogenic Amines
D000588	Amines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided