Safety, Tolerability, and Effectiveness of Rasagiline Mesylate in Patients With Parkinson's Disease

NCT ID: NCT00203138

Last Updated: 2011-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2006-12-31

Brief Summary

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Patients who completed the study TVP-1012/232 are eligible to enter the extension study to continue their rasagiline therapy for their Parkinson's disease (PD). During this study the patient's safety, tolerability of rasagiline, and effectiveness of this therapy will be monitored.

Detailed Description

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Conditions

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Parkinson's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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rasagiline mesylate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

• Patients who completed evaluations of week 52 of the TVP 1012/232 protocol, where continued rasagiline therapy is warranted, in the opinion of the principal investigator

Exclusion Criteria

• Patients having suffered adverse effects that were probably drug-related in the TVP-1012/232 study
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Teva Branded Pharmaceutical Products

Principal Investigators

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Phyllis Salzman, Ph.D.

Role: STUDY_DIRECTOR

Teva Neuroscience, Inc.

Other Identifiers

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TVP - 1012/233

Identifier Type: -

Identifier Source: org_study_id

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