Autologous T Cell Vaccine (TCV) for Multiple Sclerosis

Completed · Phase 2 · Has a placebo group

Conditions studied: Relapsing-Remitting Multiple Sclerosis

In brief

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).

Key facts

Study ID

NCT00245622

Run by

Opexa Therapeutics, Inc.

People needed

150

Starts

2006-05-01

Expected to finish

2008-09-01

Last updated by the study team

2014-03-10

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

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
• Lovelace Scientific Resources — Sarasota, Florida, United States
• Shepherd Center — Atlanta, Georgia, 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
• University of Louisville Hospital — Louisville, Kentucky, United States
• Research Nurse Specialists — Lafayette, Louisiana, 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
• University Hospital and Medical Center Stony Brook New York — Stony Brook, 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

Full record on ClinicalTrials.gov

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