Rasagiline in Advanced Parkinson's Disease Patients With Motor Fluctuations Treated With Levodopa/Carbidopa Therapy.
Information source: Teva Pharmaceutical Industries
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Parkinson's Disease
Intervention: rasagiline mesylate (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Teva Pharmaceutical Industries Official(s) and/or principal investigator(s):
Phyllis Salzman, Ph.D., Study Director, Affiliation: Teva Pharmaceutical Industries
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
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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.
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
Minimum age: 30 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Margolin Brain Institute, Fresno, California 93720, United States
Emory University, Atlanta, Georgia 30329, United States
Rush - Presbyterian St. Luke's Medical Center, Chicago, Illinois 60612, United States
Creighton University, Omaha, Nebraska 68131, United States
Long Island Jewish Medical Center, New Hyde Park, New York 11040, United States
University of Rochester, Rochester, New York 14642, United States
Pennsylvania Hospital, Philadelphia, Pennsylvania 19107, United States
CHUM-Hotel-Dieu, Montreal, Quebec H2w1T8, Canada
Additional Information
Starting date: October 2001
Last updated: January 9, 2008
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