- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00203138
Safety, Tolerability, and Effectiveness of Rasagiline Mesylate in Patients With Parkinson's Disease
April 8, 2011 updated by: Teva Branded Pharmaceutical Products R&D, Inc.
A Multicenter, Open-Label, Phase III Study for the Safety, Tolerability and Clinical Effect of Rasagiline Mesylate in Patients With Parkinson's Disease
Patients who completed the study TVP-1012/232 are eligible to enter the extension study to continue their rasagiline therapy for their Parkinson's disease (PD).
During this study the patient's safety, tolerability of rasagiline, and effectiveness of this therapy will be monitored.
Study Overview
Study Type
Interventional
Enrollment (Actual)
306
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
• Patients who completed evaluations of week 52 of the TVP 1012/232 protocol, where continued rasagiline therapy is warranted, in the opinion of the principal investigator
Exclusion Criteria:
• Patients having suffered adverse effects that were probably drug-related in the TVP-1012/232 study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tolerability - Number of patients completing study on their original treatment assignment (dose reduction and dropout)
Time Frame: 2.5 years
|
2.5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2004
Primary Completion (ACTUAL)
November 1, 2006
Study Completion (ACTUAL)
December 1, 2006
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (ESTIMATE)
September 20, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
April 12, 2011
Last Update Submitted That Met QC Criteria
April 8, 2011
Last Verified
April 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Parkinson Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Neuroprotective Agents
- Protective Agents
- Monoamine Oxidase Inhibitors
- Rasagiline
Other Study ID Numbers
- TVP - 1012/233
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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