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NCT00203138 Clinical Trial

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

Parkinson's Disease Clinical Trial

Official title:
A Multicenter, Open-Label, Phase III Study for the Safety, Tolerability and Clinical Effect of Rasagiline Mesylate in Patients With Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00203138
Other study ID # TVP - 1012/233
Secondary ID
Status Completed
Phase Phase 3
First received September 13, 2005
Last updated April 8, 2011
Start date June 2004
Est. completion date December 2006

Study information
Verified date April 2011
Source Teva Pharmaceutical Industries
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationCanada: Health Canada
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 306
Est. completion date December 2006
Est. primary completion date November 2006
Accepts healthy volunteers No
Gender Both
Age group 35 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• rasagiline mesylate

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Teva Pharmaceutical Industries

Outcome
Type Measure Description Time frame Safety issue
Primary Tolerability - Number of patients completing study on their original treatment assignment (dose reduction and dropout) 2.5 years No
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