Clinical trial NCT00595920: Open Label Extension of Prior TERMS Study to Treat Relapsing Forms of Multiple Sclerosis
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Multiple Sclerosis, Relapsing-Remitting
Clinically Isolated Syndrome
Keywords: Tovaxin
Autologous
T-cell vaccine (TCV)
Lead sponsor: Opexa Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2008-01-16
Enrollment: 116
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Evaluate Changes in Number of Combined Unique Active Lesions on Brain Magnetic Resonance Imaging (MRI)
timeFrame: Annually
Secondary outcomes:
measure: Evaluate Changes in Rate and Severity of Multiple Sclerosis (MS) Progression
timeFrame: Annually
measure: Evaluate Changes in Annualized Relapse Rate
timeFrame: Annually
Other outcomes:
Locations:
city: Cullman
country: United States
facility: North Central Neurology Associates, PC
state: Alabama
city: Phoenix
country: United States
facility: Xenoscience - 21st Century Neurology
state: Arizona
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: Berkeley
country: United States
facility: Alta Bates Summit Medical Center - East Bay Physicians Medical Group
state: California
city: Colorado Springs
country: United States
facility: Patricia A Fodor, PC
state: Colorado
city: Bradenton
country: United States
facility: Bradenton Neurology
state: Florida
city: Pompano Beach
country: United States
facility: Neurological Associates
state: Florida
city: Augusta
country: United States
facility: Medical College of Georgia - Department of Neurology
state: Georgia
city: Northbrook
country: United States
facility: Consultants in Neurology, Ltd.
state: Illinois
city: Fort Wayne
country: United States
facility: Allied Physicians Inc
state: Indiana
city: Lenexa
country: United States
facility: MidAmerica Neuroscience Institute
state: Kansas
city: Lexington
country: United States
facility: Associates in Neurology
state: Kentucky
city: Saginaw
country: United States
facility: St Mary's of Michigan - Field Neuroscience Institute
state: Michigan
city: Lebanon
country: United States
facility: Ayres & Associates Clinical Trials
state: New Hampshire
city: Albany
country: United States
facility: Upstate Clinical Research, LLC
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital - Clinical Trials Unit
state: New York
city: Charlotte
country: United States
facility: Neurology Consultants of the Carolinas, PA
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Neurology Associates
state: North Carolina
city: Akron
country: United States
facility: Neurology & Neuroscience Associates, Inc.
state: Ohio
city: Columbus
country: United States
facility: Neurological Research Institute
state: Ohio
city: Dayton
country: United States
facility: Neurology Specialists, Inc
state: Ohio
city: Portland
country: United States
facility: Providence St. Vincent Medical Center - Northwest MS Center
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Houston
country: United States
facility: The Maxine Mesinger MS Clinic/Baylor College of Medicine
state: Texas
city: Round Rock
country: United States
facility: Central Texas Neurology
state: Texas
city: San Antonio
country: United States
facility: Integra Clinical Research, LLC
state: Texas
city: Kirkland
country: United States
facility: MS Center at Evergreen
state: Washington
Study officials:
affiliation: Central Texas Neurology Consultants
name: Edward J Fox, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang J. T-cell vaccination in multiple sclerosis: immunoregulatory mechanism and prospects for therapy. Crit Rev Immunol. 2001;21(1-3):41-55.
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. doi: 10.1007/pl00007867.
citation: 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. doi: 10.1586/14760584.1.3.285.