Effectiveness of Rituximab in Pediatric OMS Patients.

Part of paid clinical trials in Springfield, Illinois.

Sponsor
National Pediatric Neuroinflammation Organization, Inc.
Study ID
NCT00244361
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Ataxia
  • Myoclonus
  • Opsoclonus
  • Opsoclonus-myoclonus Syndrome

Eligibility Criteria

Sex
ALL
Age
6 Months - 19 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jun 30, 2005
Status verified
May 2011
Primary completion
Dec 31, 2007
Completion
Dec 31, 2007

Study Design

Enrollment
25 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

Determine the effectiveness & selectivity of rituximab at depleting CSF B-cells in OMS with intrathecal B-cell expansion. This requires CSF & blood lympocyte immunophenotyping prior to the first infusion & intervals for 1 year after the final infusion.

Locations (1)

FacilityCityStateZIPSite coordinators
National Pediatric Myoclonus Center, Department of Neurology, SIU School of Medicine, 751 N Rutledge StSpringfieldIllinois62794-

Find similar trials in Springfield, IL

By research site
National Pediatric Myoclonus Center, Department of Neurology, SIU School of Medicine, 751 N Rutledge St· Springfield, IL

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