NCT00595920

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Opexa Therapeutics, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Multiple Sclerosis, Relapsing-Remitting
• Clinically Isolated Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	Tovaxin	2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required.

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2008-01-16
• Last updated: 2016-03-15
• Results posted: 2016-03-15

Locations

27 sites across 1 country: United States