Study to Evaluate the Safety and Tolerability of Rasagiline in Advanced Parkinson's Disease Patients
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
1 other identifier
interventional
254
1 country
6
Brief Summary
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/Carbidopa therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2002
Typical duration for phase_3
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedMarch 9, 2010
March 1, 2010
3.2 years
September 13, 2005
March 8, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
long-term safety and tolerability of rasagiline or levodopa/benserazide (LD/BZD) therapy
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
until commericially available
Study Arms (1)
rasagiline mesylate
EXPERIMENTALrasagiline mesylate 1 mg oral once daily
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Margolin Brain Institute
Fresno, California, 93720, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Phyllis Salzman, Ph.D.
Teva Neuroscience, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 20, 2005
Study Start
May 1, 2002
Primary Completion
July 1, 2005
Study Completion
September 1, 2006
Last Updated
March 9, 2010
Record last verified: 2010-03