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

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

— OLTERMS  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00595920
• Other study ID #: 2007-00
• Status: Terminated
• Phase: Phase 2
• First received: January 3, 2008
• Last updated: February 16, 2016
• Start date: November 2007
• Est. completion date: December 2008

Study information

• Verified date: February 2014
• Source: Opexa Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 116
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Clinically Isolated Syndrome
• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Biological:
• Tovaxin
2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required.

Locations

Country	Name	City	State
United States	Neurology & Neuroscience Associates, Inc.	Akron	Ohio
United States	Upstate Clinical Research, LLC	Albany	New York
United States	Medical College of Georgia - Department of Neurology	Augusta	Georgia
United States	Alta Bates Summit Medical Center - East Bay Physicians Medical Group	Berkeley	California
United States	Bradenton Neurology	Bradenton	Florida
United States	Neurology Consultants of the Carolinas, PA	Charlotte	North Carolina
United States	Patricia A Fodor, PC	Colorado Springs	Colorado
United States	Neurological Research Institute	Columbus	Ohio
United States	North Central Neurology Associates, PC	Cullman	Alabama
United States	Neurology Specialists, Inc	Dayton	Ohio
United States	Allied Physicians Inc	Fort Wayne	Indiana
United States	The Maxine Mesinger MS Clinic/Baylor College of Medicine	Houston	Texas
United States	MS Center at Evergreen	Kirkland	Washington
United States	Ayres & Associates Clinical Trials	Lebanon	New Hampshire
United States	MidAmerica Neuroscience Institute	Lenexa	Kansas
United States	Associates in Neurology	Lexington	Kentucky
United States	Winthrop University Hospital - Clinical Trials Unit	Mineola	New York
United States	Consultants in Neurology, Ltd.	Northbrook	Illinois
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	HOPE Research Institute	Phoenix	Arizona
United States	Xenoscience - 21st Century Neurology	Phoenix	Arizona
United States	Neurological Associates	Pompano Beach	Florida
United States	Providence St. Vincent Medical Center - Northwest MS Center	Portland	Oregon
United States	Raleigh Neurology Associates	Raleigh	North Carolina
United States	Central Texas Neurology	Round Rock	Texas
United States	St Mary's of Michigan - Field Neuroscience Institute	Saginaw	Michigan
United States	Integra Clinical Research, LLC	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Opexa Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Zhang J. T-cell vaccination for autoimmune diseases: immunologic lessons and clinical experience in multiple sclerosis. Expert Rev Vaccines. 2002 Oct;1(3):285-92. Review. — View Citation

Zhang J. T-cell vaccination in multiple sclerosis: immunoregulatory mechanism and prospects for therapy. Crit Rev Immunol. 2001;21(1-3):41-55. Review. — View Citation

Zhang JZ, Rivera VM, Tejada-Simon MV, Yang D, Hong J, Li S, Haykal H, Killian J, Zang YC. T cell vaccination in multiple sclerosis: results of a preliminary study. J Neurol. 2002 Feb;249(2):212-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate Changes in Number of Combined Unique Active Lesions on Brain Magnetic Resonance Imaging (MRI)	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.	Annually	Yes
Secondary	Evaluate Changes in Rate and Severity of Multiple Sclerosis (MS) Progression		Annually	Yes
Secondary	Evaluate Changes in Annualized Relapse Rate		Annually	Yes