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NCT00244361 · ClinicalTrials.gov registry record · Phase 1
Effectiveness of Rituximab in Pediatric OMS Patients.
A Phase 1 study, sponsored by National Pediatric Neuroinflammation Organization.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT00244361 is a Phase 1 study that has completed, run by National Pediatric Neuroinflammation Organization. The registered enrollment target is 25 participants.
The verdict
NCT00244361, a Phase 1 study, has completed, sponsored by National Pediatric Neuroinflammation Organization.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study 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.
Interventions
- DRUG rituximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2005-06 |
| Est. Completion | 2007-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00244361
The ClinicalTrials.gov registry entry for NCT00244361 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Pediatric Neuroinflammation Organization, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which rituximab is the first listed.
NCT00244361 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00244361 about?
NCT00244361 is a clinical study titled "Effectiveness of Rituximab in Pediatric OMS Patients.". 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 fi...
What is the current status of trial NCT00244361?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2005-06. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00244361?
The interventions under investigation include: rituximab (DRUG).
Who is sponsoring clinical trial NCT00244361?
This trial is sponsored by National Pediatric Neuroinflammation Organization, which has 2 total clinical trials registered on ClinicalTrials.gov.
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