Open Label Extension of Prior TERMS Study to Treat Relapsing Forms of
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
What it found
The trial ended early for another reason (see below).
Reason given: Financial Constraints
What was tested
Treatment tested
- Tovaxin
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Open Label Extension | 38 | 1 (2.6%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Evaluate Changes in Number of Combined Unique Active Lesions on Brain Magnetic Resonance Imaging (MRI)
Annually
MRI lesions
Other measures (2)
Evaluate Changes in Rate and Severity of Multiple Sclerosis (MS) Progression
Annually
Evaluate Changes in Annualized Relapse Rate
Annually
Relapses
Who could take part
Relapsing MS
Show the full criteria
Inclusion criteria
* Subjects who completed the TERMS study and received at least 1 study treatment injection * Signed and dated statement of informed consent
Exclusion criteria
* Pregnancy or breastfeeding * Experienced a serious adverse drug reaction with confirmatory relationship to Tovaxin in the TERMS study. * Withdrew from TERMS study and did not continue participating in the remaining 52-week core TERMS study assessments. * Non-compliant with TERMS study. * Diagnosis of progressive-relapsing, secondary progressive or primary progressive Multiple Sclerosis (MS) while enrolled in the TERMS study. * Medical, psychiatric or other conditions that compromise the subject's ability to give informed consent, to understand the patient information, to comply with the study protocol, or to complete the study. * Any significant change in the subject's medical condition after enrollment in the TERMS study which would have lead to his/her exclusion from participation in that study.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of this study is to further evaluate the safety and efficacy of Tovaxin in the treatment of relapsing forms of multiple sclerosis.
Papers
Background
Zhang J. T-cell vaccination in multiple sclerosis: immunoregulatory mechanism and prospects for therapy. Crit Rev Immunol. 2001;21(1-3):41-55.Background
Zhang JZ, Rivera VM, Tejada-Simon MV, Yang D, Hong J, Li S, Haykal H, Killian J, Zang YC. T cell vaccination in multiple sclerosis: results of a preliminary study. J Neurol. 2002 Feb;249(2):212-8. doi: 10.1007/pl00007867.Background
Zhang J. T-cell vaccination for autoimmune diseases: immunologic lessons and clinical experience in multiple sclerosis. Expert Rev Vaccines. 2002 Oct;1(3):285-92. doi: 10.1586/14760584.1.3.285.
Loading reviews and guidelines…
History
Started
Nov 2007
Main results due
Dec 2008
Finished
Dec 2008
Results posted
Mar 2016