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Open Label Extension of Prior TERMS Study to Treat Relapsing Forms of Multiple Sclerosis — OLTERMS  

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

Official title:
An Open-Label Extension Study to Evaluate the Safety, Tolerability and Efficacy of Subcutaneous Tovaxin in Subjects Previously Treated in the TERMS Study 2005-00

Clinical Trial Summary

The purpose of this study is to further evaluate the safety and efficacy of Tovaxin in the treatment of relapsing forms of multiple sclerosis.

Clinical Trial Description

The subjects with positive myelin-reactive T cells (MRTC) in their blood during the previous TERMS study will immediately be eligible for Tovaxin production and treatment in this open label extension study. The MRTC negative subjects will be monitored quarterly for safety, MRTC reactivity, paraclinical and clinical effect. Subjects who become MRTC positive during the monitoring phase will then be eligible for Tovaxin production and treatment in this study. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00595920
Study type Interventional
Source Opexa Therapeutics, Inc.
Contact
Status Terminated
Phase Phase 2
Start date November 2007
Completion date December 2008
View Details
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