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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.
ClinicalTrials.gov Identifier: NCT00595920
Recruitment Status : Terminated (Financial Constraints)
First Posted : January 16, 2008
Results First Posted : March 15, 2016
Last Update Posted : March 15, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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 Design

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
Primary Completion Date : December 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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 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

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 ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Opexa Therapeutics, Inc.
ClinicalTrials.gov 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.:
Tovaxin
Autologous
T-cell vaccine (TCV)

Additional relevant MeSH terms:
Sclerosis
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
Vaccines
Immunologic Factors
Physiological Effects of Drugs