Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT00595920
Status:
TERMINATED
Last Update Posted:
2016-03-15
First Post:
2008-01-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Open Label Extension of Prior TERMS Study to Treat Relapsing Forms of Multiple Sclerosis
Sponsor:
Opexa Therapeutics, Inc.
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Financial Constraints
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OLTERMS
Brief 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.
Study Oversight
Has Oversight DMC:
True
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?: