Multiple Sclerosis Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

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.

Study is for people with:

Multiple Sclerosis

Phase:

Phase 2

Estimated Enrollment:

116

Study ID:

NCT00595920

Recruitment Status:

Terminated

Sponsor:

Opexa Therapeutics, Inc.

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There are 27 Locations for this study

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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

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 2

Estimated Enrollment:

116

Study ID:

NCT00595920

Recruitment Status:

Terminated

Sponsor:


Opexa Therapeutics, Inc.

How clear is this clinincal trial information?

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