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Trial record 2 of 3 for:    tovaxin
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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)
Sponsor:
Information provided by (Responsible Party):
Opexa Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00595920
First received: January 3, 2008
Last updated: October 9, 2012
Last verified: October 2012
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

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
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open Label Extension
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 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:

Responsible Party: Opexa Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00595920     History of Changes
Other Study ID Numbers: 2007-00
Study First Received: January 3, 2008
Last Updated: October 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Opexa Therapeutics, Inc.:
Tovaxin
Autologous
TCV

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

ClinicalTrials.gov processed this record on May 23, 2013