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

This study is ongoing, but not recruiting participants.

First Received: September 13, 2005 Last Updated: February 8, 2007 History of Changes

Sponsored by:	Teva Pharmaceutical Industries
Information provided by:	Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:	NCT00203164

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.

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

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Rasagiline Rasagiline mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Safety Study
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

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:

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

Estimated Enrollment:	254
Study Start Date:	May 2002

Detailed Description:

In the double-blinded phase, patients assigned to receive placebo in study TVP 1012/133 will be randomly assigned in a 1:1 ratio to receive (blinded) rasagiline 0.5 mg or 1 mg. Patients previously treated with rasagiline 0.5 mg and rasagiline 1 mg will continue on their original treatment assignment.

Patients continuing beyond six (6) months will receive open-labeled rasagiline 1 mg/day.

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 Pharmaceutical Industries

More Information

No publications provided

Study ID Numbers:	TVP - 1012/135 Open Label
Study First Received:	September 13, 2005
Last Updated:	February 8, 2007
ClinicalTrials.gov Identifier:	NCT00203164 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Study placed in the following topic categories:

Rasagiline
Levodopa
Ganglion Cysts
Movement Disorders
Parkinson Disease
Carbidopa

Basal Ganglia Diseases
Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases
Neuroprotective Agents

Additional relevant MeSH terms:

Rasagiline
Molecular Mechanisms of Pharmacological Action
Basal Ganglia Diseases
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Diseases
Enzyme Inhibitors
Brain Diseases
Neurodegenerative Diseases

Neuroprotective Agents
Protective Agents
Pharmacologic Actions
Parkinson Disease
Movement Disorders
Therapeutic Uses
Monoamine Oxidase Inhibitors
Parkinsonian Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009