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

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ClinicalTrials.gov Identifier: NCT00203138
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : April 12, 2011
Sponsor:
Information provided by:
Teva Pharmaceutical Industries

Brief Summary:
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 or disease Intervention/treatment Phase
Parkinson's Disease Drug: rasagiline mesylate Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 306 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : June 2004
Actual Primary Completion Date : November 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Tolerability - Number of patients completing study on their original treatment assignment (dose reduction and dropout) [ Time Frame: 2.5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00203138


Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
Study Director: Phyllis Salzman, Ph.D. Teva Neuroscience, Inc.

Responsible Party: Siyu Liu, MD, VP, Global Head Clinical Operations, Teva Branded Pharmaceutical Products
ClinicalTrials.gov Identifier: NCT00203138     History of Changes
Other Study ID Numbers: TVP - 1012/233
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: April 12, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Rasagiline
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs