Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00245622
Status:
COMPLETED
Last Update Posted:
2014-03-10
First Post:
2005-10-20
Brief Title:
Autologous T Cell Vaccine TCV for Multiple Sclerosis
Sponsor:
Opexa Therapeutics Inc
Organization:
Opexa Therapeutics Inc
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Placebo-Controlled Study of Subcutaneous Tovaxin in Subjects With CIS or RR-MS
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TERMS
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-MS
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 blood to be used for vaccine production Eligible subjects will be enrolled to receive either Tovaxin or placebo and will complete baseline assessments Randomization and enrolled subjects will receive study treatment by subcutaneous injections at weeks 0 4 8 12 and 24 Subjects will be monitored by CBC serum chemistries urinalysis Expanded Disability Status Scale EDSS MSFC MSQLI magnetic resonance imaging MRI and monitor myelin reactive T cells for safety efficacy and tolerability of Tovaxin
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None