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

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00203138
First received: September 13, 2005
Last updated: April 8, 2011
Last verified: April 2011
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

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) [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]

Enrollment: 306
Study Start Date: June 2004
Study Completion Date: December 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
  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

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

No publications provided

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
Study First Received: September 13, 2005
Last Updated: April 8, 2011
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013