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Multicenter Study of Rasagiline in Parkinson's Disease Patients Using Levodopa and Experiencing Motor Fluctuations

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: NCT00203034
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : March 9, 2010
Information provided by:
Teva Pharmaceutical Industries

Brief Summary:
Study for patients currently using Levodopa/Carbidopa who will be assigned to receive either Rasagiline or Placebo

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 472 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, US and Canada, Double Blind, Randomized, Placebo-Controlled, Parallel Group Study, for the Efficacy, Tolerability and Safety of Rasagiline Mesylate in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations
Study Start Date : May 2000
Primary Completion Date : January 2003
Study Completion Date : January 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Experimental 1
0.5 mg rasagiline mesylate oral once daily
Drug: rasagiline mesylate
0.5 mg rasagiline mesylate oral once daily
Experimental: Experimental 2
1.0 mg rasagiline mesylate oral once daily
Drug: 1.0 mg rasagiline mesylate
1.0 mg rasagiline mesylate oral once daily
Placebo Comparator: Placebo
Placebo Comparator
Other: Placebo
oral placebo once daily

Primary Outcome Measures :
  1. Change from baseline in the mean total daily "OFF" time [ Time Frame: 26 weeks ]

Information from the National Library of Medicine

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

Inclusion Criteria:

Men and women with idiopathic Parkinson's disease whose diagnosis is confirmed by at least two of the cardinal signs (resting tremor, bradykinesia, rigidity) being present, without any other known or suspected cause of parkinsonism.

Subjects must experience levodopa related motor fluctuations averaging at least 2.5 hours daily in the OFF state.

Subjects must be taking optimized levodopa/carbidopa or levodopa /benserazide carbidopa/levodopa therapy (based on investigator's judgment), stable for at least 14 days prior to baseline. Subjects must be receiving at least 3 daily doses of levodopa, not including a bedtime dose.

Selegiline must be discontinued for at least 90 days prior to baseline.

Subject must be age 30 or older.

Subjects must be willing and able to give informed consent.

Exclusion Criteria:

Subjects with 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, laboratory tests, chest x-ray, or ECG for Parkinson's disease [e.g., pallidotomy, thalamotomy, and deep brain stimulation (DBS)] within the 12 months preceding the Baseline visit.

Subjects who have undergone neurosurgical transplantation are excluded regardless of when the procedure(s) was performed. No programming changes are permitted in subjects who have undergone DBS.

Participation in a previous clinical trial of rasagiline. Concomitant therapy with MAO inhibitors, reserpine, methyldopa within the past three months, or treatment with an anti-emetic or neuroleptic medication with central dopamine antagonist activity with the past six months.

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): NCT00203034

United States, Illinois
Rush - Presbyterian St. Luke's Medical Center
Chicago, Illinois, United States, 60612
United States, New York
Columbia - Presbyterian Medical Center
New York, New York, United States, 10032
University of Rochester
Rochester, New York, United States, 14642
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Teva Pharmaceutical Industries
Principal Investigator: Ira Shoulson, MD The Parkinson Study Group

Responsible Party: Siyu Liu, MD, PhD, VP I R&D, Head of Global Clinical Operations, Teva Branded Pharmaceutical Products IR&D Identifier: NCT00203034     History of Changes
Other Study ID Numbers: TV-1012/133
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
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Neuroprotective Agents
Protective Agents