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NCT02865018 · ClinicalTrials.gov registry record · Phase 1

Neuromyelitis Optica (NMO) & Cetirizine

A Phase 1 study, sponsored by Icahn School of Medicine at Mount Sinai.

Completed
Registry status
Phase 1
Development phase
16
Enrollment target

NCT02865018 is a Phase 1 study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 16 participants.

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The verdict

NCT02865018, a Phase 1 study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.

COMPLETED
Registry status
Phase 1
Development phase
16 participants
Enrollment target

Study Summary

Neuromyelitis optica (NMO) is an autoimmune disease that affects the central nervous system. Patients have relapses (also known as attacks) which are often quite severe and leave them with significant disability. Without treatment, within 5 years 50% of NMO patients are blind in one or both eyes or require walking assistance (cane, walker or wheelchair). NMO has only been relatively recently described and is fairly rare. Most NMO patients' immune systems produce abnormal antibodies against aquaporin-4 (AQP4), which is found in certain cells in the central nervous system. When these AQP4 antibodies bind to AQP4, they trigger a cascade of events involving the immune system which eventually leads to damage to the nervous system. This ultimately leads to disability, some of which is permanent. Until now, treatments for NMO have been mostly focused on decreasing production of this AQP4 antibody. However, recent experiments in animal models of NMO have shown the importance of what happens inside the central nervous system after the antibody binds to the nervous system cell. Specifically, researchers have noted the importance of a specific cell type, eosinophils, in causing damage in NMO lesions. In a recent study, researchers showed they could prevent damage from NMO by blocking eosinophils using cetirizine, which is a popular over-the-counter allergy medicine. Cetirizine is already known to be safe and well-tolerated in the general population. In this study, the researchers plan to add cetirizine on to patients' current NMO treatment. The researchers aim to show that it is safe, well-tolerated, and that with cetirizine, NMO patients have less relapses and therefore less disability over the course of the year following initiation of treatment. The researchers also plan to study how cetirizine changes the immunological profile in NMO patients by examining blood and cerebrospinal fluid.

Interventions

  • DRUG cetirizine

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2014-04
Est. Completion 2016-02
Phase Phase 1

What the Registry Record Tells You About NCT02865018

The ClinicalTrials.gov registry entry for NCT02865018 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which cetirizine is the first listed.

NCT02865018 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02865018 about?

NCT02865018 is a clinical study titled "Neuromyelitis Optica (NMO) & Cetirizine". Neuromyelitis optica (NMO) is an autoimmune disease that affects the central nervous system. Patients have relapses (also known as attacks) which are often quite severe and leave them with significant disability. Without treatment, within 5 years 50% of NMO patients are blind in one or both eyes or ...

What is the current status of trial NCT02865018?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2014-04. Estimated completion is 2016-02.

What interventions are being tested in trial NCT02865018?

The interventions under investigation include: cetirizine (DRUG).

Who is sponsoring clinical trial NCT02865018?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.