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

Stopped early · Phase 2

Conditions studied: Multiple Sclerosis, Relapsing-Remitting, Clinically Isolated Syndrome

In brief

The purpose of this study is to further evaluate the safety and efficacy of Tovaxin in the treatment of relapsing forms of multiple sclerosis.

Key facts

Study ID

NCT00595920

Run by

Opexa Therapeutics, Inc.

People needed

116

Starts

2007-11-01

Expected to finish

2008-12-01

Last updated by the study team

2016-03-15

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who completed the TERMS study and received at least 1 study treatment injection
• Signed and dated statement of informed consent

You may not qualify if…

• 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.

Where it is running

• North Central Neurology Associates, PC — Cullman, Alabama, United States
• Xenoscience - 21st Century Neurology — Phoenix, Arizona, United States
• HOPE Research Institute — Phoenix, Arizona, United States
• Alta Bates Summit Medical Center - East Bay Physicians Medical Group — Berkeley, California, United States
• Patricia A Fodor, PC — Colorado Springs, Colorado, United States
• Bradenton Neurology — Bradenton, Florida, United States
• Neurological Associates — Pompano Beach, Florida, United States
• Medical College of Georgia - Department of Neurology — Augusta, Georgia, United States
• Consultants in Neurology, Ltd. — Northbrook, Illinois, United States
• Allied Physicians Inc — Fort Wayne, Indiana, United States
• MidAmerica Neuroscience Institute — Lenexa, Kansas, United States
• Associates in Neurology — Lexington, Kentucky, United States
• St Mary's of Michigan - Field Neuroscience Institute — Saginaw, Michigan, United States
• Ayres & Associates Clinical Trials — Lebanon, New Hampshire, United States
• Upstate Clinical Research, LLC — Albany, New York, United States
• Winthrop University Hospital - Clinical Trials Unit — Mineola, New York, United States
• Neurology Consultants of the Carolinas, PA — Charlotte, North Carolina, United States
• Raleigh Neurology Associates — Raleigh, North Carolina, United States
• Neurology & Neuroscience Associates, Inc. — Akron, Ohio, United States
• Neurological Research Institute — Columbus, Ohio, United States
• Neurology Specialists, Inc — Dayton, Ohio, United States
• Providence St. Vincent Medical Center - Northwest MS Center — Portland, Oregon, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• The Maxine Mesinger MS Clinic/Baylor College of Medicine — Houston, Texas, United States
• Central Texas Neurology — Round Rock, Texas, United States

Full record on ClinicalTrials.gov

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