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

This study has been completed.

First Received: September 13, 2005 Last Updated: April 3, 2009 History of Changes

Sponsored by:	Teva Pharmaceutical Industries
Information provided by:	Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:	NCT00203138

Purpose

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.

Condition	Intervention	Phase
Parkinson's Disease	Drug: rasagiline mesylate	Phase III

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Rasagiline Rasagiline mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Safety/Efficacy Study
Official Title:	A Multicenter, Open-Label, Phase III Study for the Safety, Tolerability and Clinical Effect of Rasagiline Mesylate in Patients With Parkinson's Disease

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:

Tolerability - Number of patients completing study on their original treatment assignment (dose reduction and dropout)

Estimated Enrollment:	306
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

Detailed Description:

Multicenter, open-label study of outpatients with early PD. Patients completing the week 52 evaluation of study TVP-1012/232 will be eligible for an open-label extension. All patients will take rasagiline 1 mg per day. Participation is voluntary and a separate informed consent form will be obtained.

Eligibility

Ages Eligible for Study:	35 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00203138

Locations

United States, Illinois
Rush - Presbyterian St. Luke's Medical Center
Chicago, Illinois, United States, 60612
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Nebraska
Creighton University
Omaha, Nebraska, United States, 68131
United States, New York
University of Rochester
Rochester, New York, United States, 14642
United States, Pennsylvania
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

Teva Pharmaceutical Industries

Investigators

Study Director:

Phyllis Salzman, Ph.D.

Teva Pharmaceutical Industries

More Information

No publications provided

Study ID Numbers:	TVP - 1012/233
Study First Received:	September 13, 2005
Last Updated:	April 3, 2009
ClinicalTrials.gov Identifier:	NCT00203138 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Study placed in the following topic categories:

Rasagiline
Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases
Neuroprotective Agents

Additional relevant MeSH terms:

Rasagiline
Molecular Mechanisms of Pharmacological Action
Basal Ganglia Diseases
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Diseases
Enzyme Inhibitors
Brain Diseases
Neurodegenerative Diseases

Neuroprotective Agents
Protective Agents
Pharmacologic Actions
Parkinson Disease
Movement Disorders
Therapeutic Uses
Monoamine Oxidase Inhibitors
Parkinsonian Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009