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COMPLETEDPhase 1/2NCT02865018

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...

Lead sponsor: Icahn School of Medicine at Mount Sinai•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

Guthy Jackson Charitable Foundation

The researchers hypothesize that cetirizine, an allergy medication that acts as an eosinophil-stabilizer, will decrease the relapse rate when added to current standard therapy in patients with neuromyelitis optica. Medication compliance will be assessed by the research coordinator at each visit through discussion with the patient and pill counting.

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•18 years to 85
•Meet criteria for the diagnosis of neuromyelitis optica as outlined by Wingerchuk et al in 2006. Alternatively patients may be included if they have had an episode of myelitis or optic neuritis in combination with a positive NMO IgG antibody, as positive antibody with a first episode is highly associated with future relapse.
•Disease duration of at least 6 months
•Stable, without any NMO relapses, for the 3 months prior to the baseline assessment visit
•Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.

Exclusion Criteria

•Current therapy with daily cetirizine or another daily antihistamine for any indication
•Known hypersensitivity to cetirizine, hydroxyzine, or any component of the formulation
•Change in NMO disease-modifying therapy in the 3 months prior to baseline assessment
•Pregnancy or planning pregnancy during the study period
•Severe renal or hepatic impairment
•Inability to complete the study protocol for any reason

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: June 7, 2023Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE1/PHASE2

Enrollment16

Start dateApr 2014

Last updatedJun 7, 2023

Condition

Neuromyelitis Optica

Locations shown

Icahn School of Medicine at Mount Sinai

New York, New York

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 7, 2023Data synced to Clareo: July 13, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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