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.
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.
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.
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There are 27 Locations for this study
Cullman Alabama, 35058, United States
Phoenix Arizona, 85013, United States
Phoenix Arizona, 85050, United States
Berkeley California, 94705, United States
Colorado Springs Colorado, 80919, United States
Bradenton Florida, 34205, United States
Pompano Beach Florida, 33060, United States
Augusta Georgia, 30912, United States
Northbrook Illinois, 60062, United States
Fort Wayne Indiana, 46805, United States
Lenexa Kansas, 66214, United States
Lexington Kentucky, 40503, United States
Saginaw Michigan, 48604, United States
Lebanon New Hampshire, 03766, United States
Albany New York, 12205, United States
Mineola New York, 11501, United States
Charlotte North Carolina, 28204, United States
Raleigh North Carolina, 27607, United States
Akron Ohio, 44302, United States
Columbus Ohio, 43221, United States
Dayton Ohio, 45408, United States
Portland Oregon, 97225, United States
Philadelphia Pennsylvania, 19104, United States
Houston Texas, 77030, United States
Round Rock Texas, 78681, United States
San Antonio Texas, 78229, United States
Kirkland Washington, 98101, United States
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