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Trial record 2 of 3 for:    tovaxin

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: February 16, 2016
Last verified: February 2014

January 3, 2008
February 16, 2016
November 2007
December 2008   (final data collection date for primary outcome measure)
Evaluate Changes in Number of Combined Unique Active Lesions on Brain Magnetic Resonance Imaging (MRI) [ Time Frame: Annually ] [ Designated as safety issue: Yes ]
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.
  • Evaluate changes in total number of Gd+ lesions on brain MRI [ Time Frame: Annually ] [ Designated as safety issue: Yes ]
  • Determine safety and tolerability [ Time Frame: Annually ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00595920 on ClinicalTrials.gov Archive Site
  • Evaluate Changes in Rate and Severity of Multiple Sclerosis (MS) Progression [ Time Frame: Annually ] [ Designated as safety issue: Yes ]
  • Evaluate Changes in Annualized Relapse Rate [ Time Frame: Annually ] [ Designated as safety issue: Yes ]
  • 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 ]
  • Evaluate changes in new Gd+ lesions [ Time Frame: Annually ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Open Label Extension of Prior TERMS Study to Treat Relapsing Forms of Multiple Sclerosis
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
The purpose of this study is to further evaluate the safety and efficacy of Tovaxin in the treatment of relapsing forms of multiple sclerosis.
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.
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Multiple Sclerosis, Relapsing-Remitting
  • Clinically Isolated Syndrome
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
Experimental: Tovaxin, open-label
Tovaxin; 30-45 million autologous myelin reactive T cells
Intervention: Biological: Tovaxin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
116
December 2008
December 2008   (final data collection date for primary outcome measure)

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.
Both
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00595920
2007-00
Yes
Not Provided
Not Provided
Opexa Therapeutics, Inc.
Opexa Therapeutics, Inc.
Not Provided
Principal Investigator: Edward J Fox, MD, PhD Central Texas Neurology Consultants
Opexa Therapeutics, Inc.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP