Trial record 4 of 4 for:    opexa

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00595920
Recruitment Status : Terminated (Financial Constraints)
First Posted : January 16, 2008
Results First Posted : March 15, 2016
Last Update Posted : March 15, 2016
Information provided by (Responsible Party):
Opexa Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Relapsing-Remitting Clinically Isolated Syndrome Biological: Tovaxin Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : November 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Tovaxin, open-label
Tovaxin; 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.
Other Names:
  • Autologous TCV
  • T Cell Vaccine

Primary Outcome Measures :
  1. Evaluate Changes in Number of Combined Unique Active Lesions on Brain Magnetic Resonance Imaging (MRI) [ Time Frame: Annually ]
    This extension study was discontinued due to financial constraints of the company. Of the 38 patients dosed, 32 did not complete all 5 doses. Of the 6 patients that completed the 5 doses, 5 patients did not have a Wk 52 MRI and therefore, no efficacy results are summarized as there is no comparison data.

Secondary Outcome Measures :
  1. Evaluate Changes in Rate and Severity of Multiple Sclerosis (MS) Progression [ Time Frame: Annually ]
  2. Evaluate Changes in Annualized Relapse Rate [ Time Frame: Annually ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00595920

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Sponsors and Collaborators
Opexa Therapeutics, Inc.
Principal Investigator: Edward J Fox, MD, PhD Central Texas Neurology Consultants

Responsible Party: Opexa Therapeutics, Inc. Identifier: NCT00595920     History of Changes
Other Study ID Numbers: 2007-00
First Posted: January 16, 2008    Key Record Dates
Results First Posted: March 15, 2016
Last Update Posted: March 15, 2016
Last Verified: February 2014

Keywords provided by Opexa Therapeutics, Inc.:
T-cell vaccine (TCV)

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs