Study Stopped
Financial Constraints
Open Label Extension of Prior TERMS Study to Treat Relapsing Forms of Multiple Sclerosis
OLTERMS
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
1 other identifier
interventional
116
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2007
Shorter than P25 for phase_2
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 3, 2008
CompletedFirst Posted
Study publicly available on registry
January 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedResults Posted
Study results publicly available
March 15, 2016
CompletedMarch 15, 2016
February 1, 2014
1.1 years
January 3, 2008
January 13, 2014
February 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Evaluate Changes in Rate and Severity of Multiple Sclerosis (MS) Progression
Annually
Evaluate Changes in Annualized Relapse Rate
Annually
Study Arms (1)
Tovaxin, open-label
EXPERIMENTALTovaxin; 30-45 million autologous myelin reactive T cells
Interventions
2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required.
Eligibility Criteria
You may qualify if:
- Subjects who completed the TERMS study and received at least 1 study treatment injection
- Signed and dated statement of informed consent
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
North Central Neurology Associates, PC
Cullman, Alabama, 35058, United States
Xenoscience - 21st Century Neurology
Phoenix, Arizona, 85013, United States
HOPE Research Institute
Phoenix, Arizona, 85050, United States
Alta Bates Summit Medical Center - East Bay Physicians Medical Group
Berkeley, California, 94705, United States
Patricia A Fodor, PC
Colorado Springs, Colorado, 80919, United States
Bradenton Neurology
Bradenton, Florida, 34205, United States
Neurological Associates
Pompano Beach, Florida, 33060, United States
Medical College of Georgia - Department of Neurology
Augusta, Georgia, 30912, United States
Consultants in Neurology, Ltd.
Northbrook, Illinois, 60062, United States
Allied Physicians Inc
Fort Wayne, Indiana, 46805, United States
MidAmerica Neuroscience Institute
Lenexa, Kansas, 66214, United States
Associates in Neurology
Lexington, Kentucky, 40503, United States
St Mary's of Michigan - Field Neuroscience Institute
Saginaw, Michigan, 48604, United States
Ayres & Associates Clinical Trials
Lebanon, New Hampshire, 03766, United States
Upstate Clinical Research, LLC
Albany, New York, 12205, United States
Winthrop University Hospital - Clinical Trials Unit
Mineola, New York, 11501, United States
Neurology Consultants of the Carolinas, PA
Charlotte, North Carolina, 28204, United States
Raleigh Neurology Associates
Raleigh, North Carolina, 27607, United States
Neurology & Neuroscience Associates, Inc.
Akron, Ohio, 44302, United States
Neurological Research Institute
Columbus, Ohio, 43221, United States
Neurology Specialists, Inc
Dayton, Ohio, 45408, United States
Providence St. Vincent Medical Center - Northwest MS Center
Portland, Oregon, 97225, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
The Maxine Mesinger MS Clinic/Baylor College of Medicine
Houston, Texas, 77030, United States
Central Texas Neurology
Round Rock, Texas, 78681, United States
Integra Clinical Research, LLC
San Antonio, Texas, 78229, United States
MS Center at Evergreen
Kirkland, Washington, 98101, United States
Related Publications (3)
Zhang J. T-cell vaccination in multiple sclerosis: immunoregulatory mechanism and prospects for therapy. Crit Rev Immunol. 2001;21(1-3):41-55.
PMID: 11642613BACKGROUNDZhang 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.
PMID: 11985389BACKGROUNDZhang 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.
PMID: 12901569BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kenny Frazier, VP of Clinical Development and Regulatory Affairs
- Organization
- Opexa Therapeutics, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Edward J Fox, MD, PhD
Central Texas Neurology Consultants
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2008
First Posted
January 16, 2008
Study Start
November 1, 2007
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
March 15, 2016
Results First Posted
March 15, 2016
Record last verified: 2014-02