Status:
COMPLETED
Autologous T Cell Vaccine (TCV) for Multiple Sclerosis
Lead Sponsor:
Opexa Therapeutics, Inc.
Conditions:
Relapsing-Remitting Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
This is a 1 year study to evaluate the efficacy, safety, and tolerability of Tovaxin T cell therapy in subjects with a clinically isolated syndrome (CIS) and relapse-remitting multiple sclerosis (RR-M...
Detailed Description
A 2 arm, 52 week parallel-group of Tovaxin versus placebo in subjects with CIS or RR-MS. Subjects who provide written, informed consent will complete screening and procurement assessments and provide ...
Eligibility Criteria
Inclusion
- Aged 18 to 55 years old
- Presence of myelin reactive T cells at screening
- Diagnosis of CIS with screening MRI that fulfils the Barkhof criteria - dissemination in space
- Diagnosis of MS within the past 10 years according to the McDonald criteria (2005)
- Baseline EDSS score between 0 and 5.5 inclusively
Exclusion
- Unable to produce T cell vaccine
- Disease-modifying treatment for MS during the last 30 days and 60 days for steroidal treatments
- Diagnosis of progressive-relapsing, secondary progressive, or primary progressive MS
- Planned pregnancy, currently pregnant, or breastfeeding
- Any prior treatment with total lymphoid irradiation, cladribine, T cell or T cell receptor vaccination
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00245622
Start Date
May 1 2006
End Date
September 1 2008
Last Update
March 10 2014
Active Locations (33)
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1
North Central Neurology Associates, PC
Cullman, Alabama, United States, 35058
2
Xenoscience - 21st Century Neurology
Phoenix, Arizona, United States, 85013
3
HOPE Research Institute
Phoenix, Arizona, United States, 85050
4
Alta Bates Summit Medical Center - East Bay Physicians Medical Group
Berkeley, California, United States, 94705