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Study to Evaluate the Safety and Tolerability of Rasagiline in Advanced Parkinson's Disease Patients

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00203164
First received: September 13, 2005
Last updated: March 8, 2010
Last verified: March 2010
History of Changes
  Purpose

This is a study to look at the effectiveness, tolerability, and safety of one dose of rasagiline in advanced Parkinson's disease (PD) patients who have been treated with Levodopa/Carbidopa therapy.


Condition Intervention Phase
Parkinson's Disease
 Drug: rasagiline mesylate
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Bi-national, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Tolerability of Rasagiline Mesylate in Advanced Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Chronic Levodopa/Carbidopa Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • long-term safety and tolerability of rasagiline or levodopa/benserazide (LD/BZD) therapy [ Time Frame: until commericially available ] [ Designated as safety issue: No ]
    To evaluate the long-term safety and tolerability of rasagiline in PD patients with motor fluctuations treated with chronic levodopa/carbidopa (LD/CD) or levodopa/benserazide (LD/BZD) therapy


Enrollment: 254
Study Start Date: May 2002
Study Completion Date: September 2006
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rasagiline mesylate
rasagiline mesylate 1 mg oral once daily
 Drug: rasagiline mesylate
rasagiline mesylate 1 mg oral once daily

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have completed the Week 26 visit of TVP 1012/133 (Visit 06) in accordance with the protocol.
  • Women must be postmenopausal, surgically sterile, or using adequate birth control methods. Women of childbearing potential must have a negative pregnancy test at Baseline/Month 0.
  • Patients must be willing and able to give informed consent.

Exclusion Criteria:

  • Serious or severe, test drug-related (probable or definite) adverse reaction in study TVP 1012/133.
  • Premature discontinuation from study TVP 1012/133 for any reason.
  • A clinically significant or unstable medical or surgical condition which would preclude safe and complete study participation. Such conditions may include cardiovascular, pulmonary, hepatic, renal, or metabolic diseases; or malignancies, as determined by medical history, physical exam, skin evaluation, laboratory tests, chest x-ray, or electrocardiogram (ECG).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00203164

Locations
United States, California
Margolin Brain Institute
Fresno, California, United States, 93720
United States, Illinois
Rush - Presbyterian St. Luke's Medical Center
Chicago, Illinois, United States, 60612
United States, Nebraska
Creighton University
Omaha, Nebraska, United States, 68131
United States, New York
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
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 Neuroscience, Inc.
  More Information

No publications provided

Responsible Party: Siyu Liu, MD, PhD, VP IRD, Head of Global Clinical Operations, Teva Branded Pharmaceutical Products IR&D
ClinicalTrials.gov Identifier: NCT00203164     History of Changes
Other Study ID Numbers: TVP - 1012/135 Open Label
Study First Received: September 13, 2005
Last Updated: March 8, 2010
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