Open Label Extension of Prior TERMS Study to Treat Relapsing Forms of Multiple Sclerosis - Full Text View

Sponsored by:	Opexa Therapeutics, Inc.
Information provided by:	Opexa Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00595920

Purpose

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

Condition	Intervention	Phase
Multiple Sclerosis, Relapsing-Remitting Clinically Isolated Syndrome	Biological: Tovaxin	Phase II

MedlinePlus related topics: Multiple Sclerosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Opexa Therapeutics, Inc.:

Primary Outcome Measures:

Evaluate changes in number of combined unique active lesions on brain MRI [ Time Frame: Annually ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Evaluate changes in rate and severity of MS progression [ Time Frame: Annually ] [ Designated as safety issue: Yes ]
Evaluate changes in annualized relapse rate [ Time Frame: Annually ] [ Designated as safety issue: Yes ]

Enrollment:	100
Study Start Date:	November 2007
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Open Label Extension: Experimental 30-45 million autologous myelin reactive T cells	Biological: Tovaxin 2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required.

Detailed Description:

The subjects with positive MTRC 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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00595920

Show 27 Study Locations

Sponsors and Collaborators

Opexa Therapeutics, Inc.

Investigators

Principal Investigator:

Edward J Fox, MD, PhD

Central Texas Neurology Consultants

More Information

Publications:

Zhang J. T-cell vaccination in multiple sclerosis: immunoregulatory mechanism and prospects for therapy. Crit Rev Immunol. 2001;21(1-3):41-55. Review.

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.

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. Review.

Responsible Party:	Opexa Therapeutics, Inc ( Jim C Williams, PhD )
Study ID Numbers:	2007-00
Study First Received:	January 3, 2008
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00595920
Health Authority:	United States: Food and Drug Administration

Keywords provided by Opexa Therapeutics, Inc.:

Tovaxin
Autologous
TCV

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Demyelinating Autoimmune Diseases, CNS

Demyelinating diseases
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Disease
Pathologic Processes
Immune System Diseases
Syndrome
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009