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

Sponsored by:	Teva Pharmaceutical Industries
Information provided by:	Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:	NCT00203177

Purpose

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

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: Levodopa Rasagiline Rasagiline mesylate Carbidopa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy 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. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment:	254
Study Start Date:	October 2001
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Open label treatment	Drug: rasagiline mesylate tablet, 0.5 or 1 mg, once daily, for six months

Detailed Description:

Patients will enter this randomized, double-blind study with two active treatment arms immediately after completion of the TVP-1012/133 study. Approximately one half of the patients will receive rasagiline 0.5 mg/day and one half will receive rasagiline 1 mg/day.

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.

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00203177

Locations

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
CHUM-Hotel-Dieu
Montreal, Quebec, Canada, H2w1T8

Sponsors and Collaborators

Teva Pharmaceutical Industries

Investigators

Study Director:

Phyllis Salzman, Ph.D.

Teva Pharmaceutical Industries

More Information

Responsible Party:	Teva Neuroscience ( J. Michael Nicholas, Ph.D., Sr. Director )
Study ID Numbers:	TVP - 1012/135 Double Blind
Study First Received:	September 13, 2005
Last Updated:	January 9, 2008
ClinicalTrials.gov Identifier:	NCT00203177
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

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Monoamine Oxidase Inhibitors

Enzyme Inhibitors
Central Nervous System Agents
Protective Agents
Neuroprotective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009