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Effectiveness, Tolerability and Safety of Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa

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ClinicalTrials.gov Identifier: NCT00203060
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : April 12, 2011
Sponsor:
Information provided by:
Teva Pharmaceutical Industries

Brief Summary:
Study to look at the effectiveness, tolerability and safety of two doses of Study Medication in Early Parkinson's Disease (PD) Patients who have not been treated with Levodopa.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Rasagiline Mesylate Drug: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 404 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Phase III Clinical Trial For The Efficacy, Tolerability And Safety Of Two Doses Of Rasagiline Mesylate In Early Parkinson's Disease (PD) Patients Not Treated With Levodopa
Study Start Date : July 1997
Actual Primary Completion Date : July 2000
Actual Study Completion Date : July 2000

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
Rasagiline treatment
Drug: Rasagiline Mesylate
tablet, 1 or 2 mg, daily, 58 weeks
Placebo Comparator: B
placebo arm
Drug: placebo
tablet, once daily, 58 weeks



Primary Outcome Measures :
  1. The primary objective is to assess the safety and efficacy of rasagiline in PD subjects, not receiving or requiring carbidopa/levodopa therapy. The primary efficacy measure will be the change in total UPDRS score, calculated from baseline to 26 weeks. [ Time Frame: 58 weeks ]


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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:

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

Subjects must be age 35 years or older.

Subjects not taking or requiring anti-parkinsonian medications, except for anticholinergics.

Exclusion Criteria:

Subjects with unstable systemic medical problems or clinically significant malignancy, with particular attention to clinically significant or unstable vascular disease


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): NCT00203060


Sponsors and Collaborators
Teva Neuroscience, Inc.
Investigators
Study Director: Sheila Oren, MD Teva Pharmaceutical Industries, Ltd.

Responsible Party: J. Michael Nicholas, Ph.D. Sr. Director, Teva Neuroscience
ClinicalTrials.gov Identifier: NCT00203060     History of Changes
Other Study ID Numbers: TVP-1012/232
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
Levodopa
Rasagiline
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