Open Label Extension of Prior TERMS Study to Treat Relapsing Forms of Multiple Sclerosis (OLTERMS)
The purpose of this study is to further evaluate the safety and efficacy of Tovaxin in the treatment of relapsing forms of multiple sclerosis.
Multiple Sclerosis, Relapsing-Remitting
Clinically Isolated Syndrome
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Evaluate changes in number of combined unique active lesions on brain MRI [ Time Frame: Annually ] [ Designated as safety issue: Yes ]
- Evaluate changes in rate and severity of MS progression [ Time Frame: Annually ] [ Designated as safety issue: Yes ]
- Evaluate changes in annualized relapse rate [ Time Frame: Annually ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2007|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Experimental: Open Label Extension
30-45 million autologous myelin reactive T cells
2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required.
The subjects with positive MTRC 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00595920
Show 27 Study Locations
|Principal Investigator:||Edward J Fox, MD, PhD||Central Texas Neurology Consultants|