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Trial record 2 of 4 for:    "Opexa Therapeutics, Inc." [Exact]

Autologous T Cell Vaccine (TCV) for Multiple Sclerosis (TERMS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Opexa Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00245622
First received: October 20, 2005
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

This is a 1 year study to evaluate the efficacy, safety, and tolerability of Tovaxin T cell therapy in subjects with a clinically isolated syndrome (CIS) and relapse-remitting multiple sclerosis (RR-MS).


Condition Intervention Phase
Relapsing-Remitting Multiple Sclerosis
Biological: Tovaxin Autologous T cell vaccine
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Subcutaneous Tovaxin in Subjects With CIS or RR-MS

Resource links provided by NLM:


Further study details as provided by Opexa Therapeutics, Inc.:

Primary Outcome Measures:
  • To evaluate the efficacy, safety, and tolerability of Tovaxin TCV in subjects with CIS or RR-MS [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate biomarkers of efficacy of Tovaxin TCV and effects of Tovaxin TCV on epitope spreading [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: May 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tovaxin Autologous T cell vaccine
2.0 mL subcutaneous formulated with 30-45 million autologous myelin reactive T cells
Biological: Tovaxin Autologous T cell vaccine
subcutaneous injections administered by healthcare provider at weeks 0, 4, 8, 12, and 24
Placebo Comparator: Placebo
2.0 mL subcutaneous injections without autologous myelin reactive T cells
Biological: Placebo
subcutaneous injections administered by healthcare provider at weeks 0, 4, 8, 12, and 24

Detailed Description:

A 2 arm, 52 week parallel-group of Tovaxin versus placebo in subjects with CIS or RR-MS. Subjects who provide written, informed consent will complete screening and procurement assessments and provide blood to be used for vaccine production. Eligible subjects will be enrolled to receive either Tovaxin or placebo and will complete baseline assessments. Randomization and enrolled subjects will receive study treatment by subcutaneous injections at weeks 0, 4, 8, 12, and 24. Subjects will be monitored by CBC, serum chemistries, urinalysis, Expanded Disability Status Scale (EDSS), MSFC, MSQLI, magnetic resonance imaging (MRI), and monitor myelin reactive T cells for safety, efficacy, and tolerability of Tovaxin.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 18 to 55 years old
  • Presence of myelin reactive T cells at screening
  • Diagnosis of CIS with screening MRI that fulfils the Barkhof criteria - dissemination in space
  • Diagnosis of MS within the past 10 years according to the McDonald criteria (2005)
  • Baseline EDSS score between 0 and 5.5 inclusively

Exclusion Criteria:

  • Unable to produce T cell vaccine
  • Disease-modifying treatment for MS during the last 30 days and 60 days for steroidal treatments
  • Diagnosis of progressive-relapsing, secondary progressive, or primary progressive MS
  • Planned pregnancy, currently pregnant, or breastfeeding
  • Any prior treatment with total lymphoid irradiation, cladribine, T cell or T cell receptor vaccination
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00245622

  Hide Study Locations
Locations
United States, Alabama
North Central Neurology Associates, PC
Cullman, Alabama, United States, 35058
United States, Arizona
HOPE Research Institute
Phoenix, Arizona, United States, 85050
Xenoscience - 21st Century Neurology
Phoenix, Arizona, United States, 85013
United States, California
Alta Bates Summit Medical Center - East Bay Physicians Medical Group
Berkeley, California, United States, 94705
United States, Colorado
Patricia A Fodor, PC
Colorado Springs, Colorado, United States, 80919
United States, Florida
Bradenton Neurology
Bradenton, Florida, United States, 34205
Neurological Associates
Pompano Beach, Florida, United States, 33060
Lovelace Scientific Resources
Sarasota, Florida, United States, 34233
United States, Georgia
Shepherd Center
Atlanta, Georgia, United States, 30309
Medical College of Georgia - Department of Neurology
Augusta, Georgia, United States, 30912
United States, Illinois
Consultants in Neurology, Ltd.
Northbrook, Illinois, United States, 60062
United States, Indiana
Allied Physicians Inc
Fort Wayne, Indiana, United States, 46805
United States, Kansas
MidAmerica Neuroscience Institute
Lenexa, Kansas, United States, 66214
United States, Kentucky
Associates in Neurology
Lexington, Kentucky, United States, 40503
University of Louisville Hospital
Louisville, Kentucky, United States, 40202
United States, Louisiana
Research Nurse Specialists
Lafayette, Louisiana, United States, 70503
United States, Michigan
St Mary's of Michigan - Field Neuroscience Institute
Saginaw, Michigan, United States, 48604
United States, New Hampshire
Ayres & Associates Clinical Trials
Lebanon, New Hampshire, United States, 03766
United States, New York
Upstate Clinical Research, LLC
Albany, New York, United States, 12205
Winthrop University Hospital - Clinical Trials Unit
Mineola, New York, United States, 11501
University Hospital and Medical Center Stony Brook New York
Stony Brook, New York, United States, 11794-8121
United States, North Carolina
Neurology Consultants of the Carolinas, PA
Charlotte, North Carolina, United States, 28204
Raleigh Neurology Associates
Raleigh, North Carolina, United States, 27607
United States, Ohio
Neurology & Neuroscience Associates, Inc.
Akron, Ohio, United States, 44302
Neurological Research Institute
Columbus, Ohio, United States, 43221
Neurology Specialists, Inc
Dayton, Ohio, United States, 45408
United States, Oregon
Providence St. Vincent Medical Center - Northwest MS Center
Portland, Oregon, United States, 97225
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
The Maxine Mesinger MS Clinic/Baylor College of Medicine
Houston, Texas, United States, 77030
Central Texas Neurology
Round Rock, Texas, United States, 78681
Integra Clinical Research, LLC
San Antonio, Texas, United States, 78229
United States, Washington
MS Center at Evergreen
Kirkland, Washington, United States, 98101
United States, West Virginia
Capitol Neurology
Charleston, West Virginia, United States, 25301
Sponsors and Collaborators
Opexa Therapeutics, Inc.
Investigators
Study Chair: Edward J Fox, M.D., Ph.D. Central Texas Neurology Consultants
Study Director: Jaye Thompson, Ph.D. Opexa Therapeutics, Inc.
  More Information

Additional Information:
Publications:
Fox E, Markowitz C, Cohan S, Wynn D. TERMS Trial TCV Secondary Analysis of Clinical and Immunological Outcoms in Patients with Relapsing Remitting MS. Poster presentation P06.132 at the 61st Annual Meeting of the American Academy of Neurology (AAN) on 01 May 2009.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Opexa Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00245622     History of Changes
Other Study ID Numbers: 2005-00
Study First Received: October 20, 2005
Last Updated: February 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Opexa Therapeutics, Inc.:
Phase 2b Tovaxin
Clinically Isolated Syndrome (CIS)
Relapse-Remitting Multiple Sclerosis (RR-MS)

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 23, 2014