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

This study has been terminated.
(Financial Constraints)
Information provided by (Responsible Party):
Opexa Therapeutics, Inc. Identifier:
First received: January 3, 2008
Last updated: February 16, 2016
Last verified: February 2014
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 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

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

Primary Outcome Measures:
  • 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:
  • Evaluate Changes in Rate and Severity of Multiple Sclerosis (MS) Progression [ Time Frame: Annually ]
  • Evaluate Changes in Annualized Relapse Rate [ Time Frame: Annually ]

Enrollment: 116
Study Start Date: November 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   Child, Adult, Senior
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00595920

  Hide Study Locations
United States, Alabama
North Central Neurology Associates, PC
Cullman, Alabama, United States, 35058
United States, Arizona
Xenoscience - 21st Century Neurology
Phoenix, Arizona, United States, 85013
HOPE Research Institute
Phoenix, Arizona, United States, 85050
United States, California
Alta Bates Summit Medical Center - East Bay Physicians Medical Group
Berkeley, California, United States, 94705
United States, Colorado
Patricia A Fodor, PC
Colorado Springs, Colorado, United States, 80919
United States, Florida
Bradenton Neurology
Bradenton, Florida, United States, 34205
Neurological Associates
Pompano Beach, Florida, United States, 33060
United States, Georgia
Medical College of Georgia - Department of Neurology
Augusta, Georgia, United States, 30912
United States, Illinois
Consultants in Neurology, Ltd.
Northbrook, Illinois, United States, 60062
United States, Indiana
Allied Physicians Inc
Fort Wayne, Indiana, United States, 46805
United States, Kansas
MidAmerica Neuroscience Institute
Lenexa, Kansas, United States, 66214
United States, Kentucky
Associates in Neurology
Lexington, Kentucky, United States, 40503
United States, Michigan
St Mary's of Michigan - Field Neuroscience Institute
Saginaw, Michigan, United States, 48604
United States, New Hampshire
Ayres & Associates Clinical Trials
Lebanon, New Hampshire, United States, 03766
United States, New York
Upstate Clinical Research, LLC
Albany, New York, United States, 12205
Winthrop University Hospital - Clinical Trials Unit
Mineola, New York, United States, 11501
United States, North Carolina
Neurology Consultants of the Carolinas, PA
Charlotte, North Carolina, United States, 28204
Raleigh Neurology Associates
Raleigh, North Carolina, United States, 27607
United States, Ohio
Neurology & Neuroscience Associates, Inc.
Akron, Ohio, United States, 44302
Neurological Research Institute
Columbus, Ohio, United States, 43221
Neurology Specialists, Inc
Dayton, Ohio, United States, 45408
United States, Oregon
Providence St. Vincent Medical Center - Northwest MS Center
Portland, Oregon, United States, 97225
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
The Maxine Mesinger MS Clinic/Baylor College of Medicine
Houston, Texas, United States, 77030
Central Texas Neurology
Round Rock, Texas, United States, 78681
Integra Clinical Research, LLC
San Antonio, Texas, United States, 78229
United States, Washington
MS Center at Evergreen
Kirkland, Washington, United States, 98101
Sponsors and Collaborators
Opexa Therapeutics, Inc.
Principal Investigator: Edward J Fox, MD, PhD Central Texas Neurology Consultants
  More Information

Responsible Party: Opexa Therapeutics, Inc. Identifier: NCT00595920     History of Changes
Other Study ID Numbers: 2007-00
Study First Received: January 3, 2008
Results First Received: January 13, 2014
Last Updated: February 16, 2016

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 processed this record on April 28, 2017