Safety, Tolerability, and Effectiveness of Rasagiline Mesylate in Patients With Parkinson's Disease
This study has been completed.
Sponsor:
Teva Pharmaceutical Industries
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00203138
First received: September 13, 2005
Last updated: April 8, 2011
Last verified: April 2011
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | April 8, 2011 | ||||
| Start Date ICMJE | June 2004 | ||||
| Primary Completion Date | November 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE |
Tolerability - Number of patients completing study on their original treatment assignment (dose reduction and dropout) | ||||
| Change History | Complete list of historical versions of study NCT00203138 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Safety, Tolerability, and Effectiveness of Rasagiline Mesylate in Patients With Parkinson's Disease | ||||
| Official Title ICMJE | A Multicenter, Open-Label, Phase III Study for the Safety, Tolerability and Clinical Effect of Rasagiline Mesylate in Patients With Parkinson's Disease | ||||
| Brief 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Parkinson's Disease | ||||
| Intervention ICMJE | Drug: rasagiline mesylate | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 306 | ||||
| Completion Date | December 2006 | ||||
| Primary Completion Date | November 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Both | ||||
| Ages | 35 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00203138 | ||||
| Other Study ID Numbers ICMJE | TVP - 1012/233 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Siyu Liu, MD, VP, Global Head Clinical Operations, Teva Branded Pharmaceutical Products | ||||
| Study Sponsor ICMJE | Teva Pharmaceutical Industries | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Teva Pharmaceutical Industries | ||||
| Verification Date | April 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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