Safety, Tolerability, and Effectiveness of Rasagiline Mesylate in Patients With Parkinson's Disease

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00203138
First received: September 13, 2005
Last updated: April 8, 2011
Last verified: April 2011

September 13, 2005
April 8, 2011
June 2004
November 2006   (final data collection date for primary outcome measure)
Tolerability - Number of patients completing study on their original treatment assignment (dose reduction and dropout) [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
Tolerability - Number of patients completing study on their original treatment assignment (dose reduction and dropout)
Complete list of historical versions of study NCT00203138 on ClinicalTrials.gov Archive Site
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Safety, Tolerability, and Effectiveness of Rasagiline Mesylate in Patients With Parkinson's Disease
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.

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Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Parkinson's Disease
Drug: rasagiline mesylate
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
306
December 2006
November 2006   (final data collection date for primary outcome measure)

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

Both
35 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00203138
TVP - 1012/233
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Siyu Liu, MD, VP, Global Head Clinical Operations, Teva Branded Pharmaceutical Products
Teva Pharmaceutical Industries
Not Provided
Study Director: Phyllis Salzman, Ph.D. Teva Neuroscience, Inc.
Teva Pharmaceutical Industries
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP