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Sponsored by: |
Opexa Therapeutics, Inc. |
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Information provided by: | Opexa Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT00595920 |
The purpose of this study is to further evaluate the safety and efficacy of Tovaxin in the treatment of relapsing forms of multiple sclerosis.
Condition | Intervention | Phase |
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Multiple Sclerosis, Relapsing-Remitting Clinically Isolated Syndrome |
Biological: Tovaxin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 100 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Open Label Extension: Experimental
30-45 million autologous myelin reactive T cells
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Biological: Tovaxin
2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required.
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The subjects with positive MTRC 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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Edward J Fox, MD, PhD | Central Texas Neurology Consultants |
Responsible Party: | Opexa Therapeutics, Inc ( Jim C Williams, PhD ) |
Study ID Numbers: | 2007-00 |
Study First Received: | January 3, 2008 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00595920 |
Health Authority: | United States: Food and Drug Administration |
Tovaxin Autologous TCV |
Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases Demyelinating Autoimmune Diseases, CNS |
Demyelinating diseases Sclerosis Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases of the Nervous System |
Disease Pathologic Processes Immune System Diseases Syndrome Nervous System Diseases |