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

Phase 2

Terminated

• Conditions: Clinically Isolated Syndrome; Multiple Sclerosis, Relapsing-Remitting
• Interventions: Biological: Tovaxin

• Registration Number: NCT00595920
• Lead Sponsor: Opexa Therapeutics, Inc.

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.

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 Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-01-03
• Study First Submitted QC: 2008-01-04
• Study First Posted: 2008-01-16
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Results First Submitted: 2014-01-13
• Status Verified: 2014-02
• Results First Submitted QC: 2016-02-16
• Last Update Submitted: 2016-02-16
• Results First Posted: 2016-03-15
• Last Update Posted: 2016-03-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 116

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tovaxin, open-label	Tovaxin	Tovaxin; 30-45 million autologous myelin reactive T cells

Primary Outcome Measures

Name	Time	Method
Evaluate Changes in Number of Combined Unique Active Lesions on Brain Magnetic Resonance Imaging (MRI)	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

Name	Time	Method
Evaluate Changes in Rate and Severity of Multiple Sclerosis (MS) Progression	Annually
Evaluate Changes in Annualized Relapse Rate	Annually

Trial Locations

Locations (27)

North Central Neurology Associates, PC; 🇺🇸 Cullman, Alabama, United States

Bradenton Neurology; 🇺🇸 Bradenton, Florida, United States

Raleigh Neurology Associates; 🇺🇸 Raleigh, North Carolina, United States

Consultants in Neurology, Ltd.; 🇺🇸 Northbrook, Illinois, United States

MS Center at Evergreen; 🇺🇸 Kirkland, Washington, United States

Alta Bates Summit Medical Center - East Bay Physicians Medical Group; 🇺🇸 Berkeley, California, United States

Medical College of Georgia - Department of Neurology; 🇺🇸 Augusta, Georgia, United States

Upstate Clinical Research, LLC; 🇺🇸 Albany, New York, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Neurology Consultants of the Carolinas, PA; 🇺🇸 Charlotte, North Carolina, United States

Ayres & Associates Clinical Trials; 🇺🇸 Lebanon, New Hampshire, United States

MidAmerica Neuroscience Institute; 🇺🇸 Lenexa, Kansas, United States

Allied Physicians Inc; 🇺🇸 Fort Wayne, Indiana, United States

Neurology & Neuroscience Associates, Inc.; 🇺🇸 Akron, Ohio, United States

Providence St. Vincent Medical Center - Northwest MS Center; 🇺🇸 Portland, Oregon, United States

St Mary's of Michigan - Field Neuroscience Institute; 🇺🇸 Saginaw, Michigan, United States

Xenoscience - 21st Century Neurology; 🇺🇸 Phoenix, Arizona, United States

Winthrop University Hospital - Clinical Trials Unit; 🇺🇸 Mineola, New York, United States

Neurology Specialists, Inc; 🇺🇸 Dayton, Ohio, United States

Central Texas Neurology; 🇺🇸 Round Rock, Texas, United States

Neurological Research Institute; 🇺🇸 Columbus, Ohio, United States

The Maxine Mesinger MS Clinic/Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

Integra Clinical Research, LLC; 🇺🇸 San Antonio, Texas, United States

HOPE Research Institute; 🇺🇸 Phoenix, Arizona, United States

Patricia A Fodor, PC; 🇺🇸 Colorado Springs, Colorado, United States

Neurological Associates; 🇺🇸 Pompano Beach, Florida, United States

Associates in Neurology; 🇺🇸 Lexington, Kentucky, United States