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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: Completed Phase 1 study, sponsored by National Pediatric Neuroinflammation Organization.
NCT00244361 is a Phase 1 study that has completed, run by National Pediatric Neuroinflammation Organization. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00244361 record still lists
NCT00244361 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 1 intervention - of which rituximab is the first listed.
NCT00244361 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00244361's enrollment target sits among peer trials
25 1495th of 2000 higher than 481 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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