Neuromyelitis Optica (NMO) & Cetirizine

NCT02865018 | Completed Phase 1 Results

• 1 other identifier: 13-1513
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuromyelitis Optica

Keywords

Neuromyelitis Optica; Cetirizine

Outcome Measures

Primary Outcomes (1)

• Annualized Relapse Rate Before Cetirizine

  Relapses defined as "patient-reported symptoms or objectively observed signs typical of an acute inflammatory demyelinating event in the CNS, with duration of at least 24 hours, in the absence of fever or infection." The on study ARR was calculated as the number of relapses during the study divided by the length of time in the study.

  Baseline and 1 year

Secondary Outcomes (3)

• Epworth Sleepiness Scale

  Baseline and 1 year

• Expanded Disability Status Scale (EDSS)

  Baseline and 1 year

• Eotaxin Plasma Levels

  6 months

Study Arms (1)

cetirizine

EXPERIMENTAL

10mg oral each day

Drug: cetirizine

Interventions

cetirizine DRUG

Also known as: Zyrtec

cetirizine

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Guthy Jackson Charitable Foundation: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Neuromyelitis Optica

Interventions

Cetirizine

Condition Hierarchy (Ancestors)

Myelitis, Transverse; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Demyelinating Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hydroxyzine; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Small sample size and lack of a control group.

Results Point of Contact

• Title: Ilana Katz Sand
• Organization: Icahn School of Medicine at Mount Sinai, Corrine Goldsmith Dickinson Center for MS

ilana.katzsand@mssm.edu

212-241-6854

Study Officials

• Ilana Katz Sand, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 12, 2016
• Study Start: April 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: June 7, 2023
• Results First Posted: June 7, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)