Rasagiline in Advanced Parkinson's Disease Patients With Motor Fluctuations Treated With Levodopa/Carbidopa Therapy.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00203177
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : March 9, 2010
Information provided by:
Teva Pharmaceutical Industries

Brief Summary:
Study to look at the effectiveness, tolerability and safety of two doses of Rasagiline (0.5 mg and 1mg) in advanced Parkinson's Disease (PD) Patients who have been treated with Levodopa/Carbidopa therapy.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: rasagiline mesylate Drug: rasagiline mesylate 1.0 mg Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 254 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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.
Study Start Date : October 2001
Actual Primary Completion Date : December 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Experimental 1
0.5 mg rasagiline mesylate oral once daily
Drug: rasagiline mesylate
0.5 rasagiline mesylate

Experimental: Expermental 2
1.0 mg rasagiline mesylate oral once daily
Drug: rasagiline mesylate 1.0 mg
1.0 mg rasagiline mesylate

Primary Outcome Measures :
  1. long-term safety and tolerability of rasagiline [ Time Frame: 6 months ]
    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.

Secondary Outcome Measures :
  1. long- term clinical effect of rasagiline [ Time Frame: 6 months ]
    To assess the long- term clinical effect of rasagiline on the course of the disease.

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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, metabolic diseases or malignancies as determined by medical history, physical exam, skin evaluation, laboratory tests, chest x-ray, or ECG.

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 identifier (NCT number): NCT00203177

United States, California
Margolin Brain Institute
Fresno, California, United States, 93720
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30329
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
Canada, Quebec
Montreal, Quebec, Canada, H2w1T8
Sponsors and Collaborators
Teva Pharmaceutical Industries
Study Director: Phyllis Salzman, Ph.D. Teva Neuroscience, Inc.

Responsible Party: Siyu Liu, MD, PhD, VP IR&D, Head of Global Clinical Operations, Teva Branded Pharmaceutical Products IR&D Identifier: NCT00203177     History of Changes
Other Study ID Numbers: TVP - 1012/135 Double Blind
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: March 9, 2010
Last Verified: March 2010

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors
Monoamine Oxidase Inhibitors
Neuroprotective Agents
Protective Agents