Open Label Extension of Prior TERMS Study to Treat Relapsing Forms of Multiple Sclerosis (OLTERMS)

Opexa Therapeutics

Status and phase

Terminated

Phase 2

Conditions

Multiple Sclerosis, Relapsing-Remitting

Clinically Isolated Syndrome

Treatments

Biological: Tovaxin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00595920

2007-00

Details and patient eligibility

About

The purpose of this study is to further evaluate the safety and efficacy of Tovaxin in the treatment of relapsing forms of multiple sclerosis.

Full 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.

Enrollment

116 patients

Sex

All

Volunteers

No Healthy Volunteers

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.