Effectiveness of Rituximab in Pediatric OMS Patients.
Status:
Completed
Trial end date:
2007-12-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to reduce the symptoms of OMS by testing rituximab (Rituxan®),
to remove B lymphocytes that make antibodies and trigger brain inflammation. Evidence
suggests that autoimmune brain inflammation causes the symptoms of OMS. This study of blood
and spinal fluid intends to find out what effect rituximab has on OMS and on the spinal fluid
B-cells.
Rituximab targets and destroys B-cells, which make antibodies that can attack the brain and
cause may OMS. It is infused through a vein over a period of several hours. Rituximab has
been used widely and studied extensively since its approval in 1997 by the U.S. Food and Drug
Administration (FDA) for non-Hodgkin's B-cell Lymphoma (NHL). Today, more than 300,000
patients have received rituximab, and it is part of more than 200 completed, ongoing, or
planned clinical trials. Rituximab is not FDA-approved for OMS.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Pediatric Myoclonus Center National Pediatric Neuroinflammation Organization, Inc.