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

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting, Clinically Isolated Syndrome

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tovaxin
Sponsored by
Opexa Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting focused on measuring Tovaxin, Autologous, T-cell vaccine (TCV)

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • North Central Neurology Associates, PC
  • Xenoscience - 21st Century Neurology
  • HOPE Research Institute
  • Alta Bates Summit Medical Center - East Bay Physicians Medical Group
  • Patricia A Fodor, PC
  • Bradenton Neurology
  • Neurological Associates
  • Medical College of Georgia - Department of Neurology
  • Consultants in Neurology, Ltd.
  • Allied Physicians Inc
  • MidAmerica Neuroscience Institute
  • Associates in Neurology
  • St Mary's of Michigan - Field Neuroscience Institute
  • Ayres & Associates Clinical Trials
  • Upstate Clinical Research, LLC
  • Winthrop University Hospital - Clinical Trials Unit
  • Neurology Consultants of the Carolinas, PA
  • Raleigh Neurology Associates
  • Neurology & Neuroscience Associates, Inc.
  • Neurological Research Institute
  • Neurology Specialists, Inc
  • Providence St. Vincent Medical Center - Northwest MS Center
  • University of Pennsylvania
  • The Maxine Mesinger MS Clinic/Baylor College of Medicine
  • Central Texas Neurology
  • Integra Clinical Research, LLC
  • MS Center at Evergreen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tovaxin, open-label

Arm Description

Tovaxin; 30-45 million autologous myelin reactive T cells

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Evaluate Changes in Rate and Severity of Multiple Sclerosis (MS) Progression
Evaluate Changes in Annualized Relapse Rate

Full Information

First Posted
January 3, 2008
Last Updated
February 16, 2016
Sponsor
Opexa Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00595920
Brief Title
Open Label Extension of Prior TERMS Study to Treat Relapsing Forms of Multiple Sclerosis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Terminated
Why Stopped
Financial Constraints
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Opexa Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting, Clinically Isolated Syndrome
Keywords
Tovaxin, Autologous, T-cell vaccine (TCV)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tovaxin, open-label
Arm Type
Experimental
Arm Description
Tovaxin; 30-45 million autologous myelin reactive T cells
Intervention Type
Biological
Intervention Name(s)
Tovaxin
Other Intervention Name(s)
Autologous TCV, T Cell Vaccine
Intervention Description
2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required.
Primary Outcome Measure Information:
Title
Evaluate Changes in Number of Combined Unique Active Lesions on Brain Magnetic Resonance Imaging (MRI)
Description
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.
Time Frame
Annually
Secondary Outcome Measure Information:
Title
Evaluate Changes in Rate and Severity of Multiple Sclerosis (MS) Progression
Time Frame
Annually
Title
Evaluate Changes in Annualized Relapse Rate
Time Frame
Annually

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward J Fox, MD, PhD
Organizational Affiliation
Central Texas Neurology Consultants
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Central Neurology Associates, PC
City
Cullman
State/Province
Alabama
ZIP/Postal Code
35058
Country
United States
Facility Name
Xenoscience - 21st Century Neurology
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
HOPE Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Alta Bates Summit Medical Center - East Bay Physicians Medical Group
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
Patricia A Fodor, PC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80919
Country
United States
Facility Name
Bradenton Neurology
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Neurological Associates
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33060
Country
United States
Facility Name
Medical College of Georgia - Department of Neurology
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Consultants in Neurology, Ltd.
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Facility Name
Allied Physicians Inc
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46805
Country
United States
Facility Name
MidAmerica Neuroscience Institute
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66214
Country
United States
Facility Name
Associates in Neurology
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
St Mary's of Michigan - Field Neuroscience Institute
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48604
Country
United States
Facility Name
Ayres & Associates Clinical Trials
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States
Facility Name
Upstate Clinical Research, LLC
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Facility Name
Winthrop University Hospital - Clinical Trials Unit
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Neurology Consultants of the Carolinas, PA
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Raleigh Neurology Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Neurology & Neuroscience Associates, Inc.
City
Akron
State/Province
Ohio
ZIP/Postal Code
44302
Country
United States
Facility Name
Neurological Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
Neurology Specialists, Inc
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45408
Country
United States
Facility Name
Providence St. Vincent Medical Center - Northwest MS Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
The Maxine Mesinger MS Clinic/Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Central Texas Neurology
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Integra Clinical Research, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
MS Center at Evergreen
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11642613
Citation
Zhang J. T-cell vaccination in multiple sclerosis: immunoregulatory mechanism and prospects for therapy. Crit Rev Immunol. 2001;21(1-3):41-55.
Results Reference
background
PubMed Identifier
11985389
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.
Results Reference
background
PubMed Identifier
12901569
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.
Results Reference
background

Learn more about this trial

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

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