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Neuromyelitis Optica (NMO) & Cetirizine

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ClinicalTrials.gov Identifier: NCT02865018
Recruitment Status : Completed
First Posted : August 12, 2016
Last Update Posted : August 12, 2016
Sponsor:
Collaborator:
Guthy Jackson Foundation
Information provided by (Responsible Party):
Ilana Katz Sand, Icahn School of Medicine at Mount Sinai

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.


Condition or disease Intervention/treatment Phase
Neuromyelitis Optica Drug: cetirizine Phase 1 Phase 2

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, add-on Trial of Cetirizine for Patients With Neuromyelitis Optica
Study Start Date : April 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016


Arm Intervention/treatment
Experimental: cetirizine
10mg oral each day
Drug: cetirizine
Other Name: Zyrtec




Primary Outcome Measures :
  1. Annualized relapse rate before cetirizine [ Time Frame: Baseline ]
  2. Annualized relapse rate after cetirizine [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Epworth Sleepiness Scale [ Time Frame: Baseline ]
    Sedation as measured by Epworth Sleepiness Scale. The test is a list of eight situations in which you rate your tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing. Total score 0 to 24 from unlikelihood of abnormally sleep to excessively sleepy.

  2. Epworth Sleepiness Scale [ Time Frame: 3 months ]
    Sedation as measured by Epworth Sleepiness Scale

  3. Epworth Sleepiness Scale [ Time Frame: 6 months ]
    Sedation as measured by Epworth Sleepiness Scale

  4. Epworth Sleepiness Scale [ Time Frame: 1 year ]
    Sedation as measured by Epworth Sleepiness Scale

  5. Expanded Disability Status Scale (EDSS) [ Time Frame: Baseline ]
    Disability as measured by Expanded Disability Status Scale (EDSS). The EDSS provides a total score on a scale from 0 to 10, from normal function to lessening function with higher score, with 10 being death due to MS.

  6. EDSS [ Time Frame: 1 year ]
    Disability as measured by Expanded Disability Status Scale (EDSS)

  7. Eosinophil counts in the blood [ Time Frame: Baseline ]
    Immunological measures related to eosinophil activity

  8. Eosinophil counts in the blood [ Time Frame: 3 months ]
    Immunological measures related to eosinophil activity

  9. Eosinophil counts in the blood [ Time Frame: 6 months ]
    Immunological measures related to eosinophil activity



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02865018


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Guthy Jackson Foundation
Investigators
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Principal Investigator: Ilana Katz Sand, MD Icahn School of Medicine at Mount Sinai

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Responsible Party: Ilana Katz Sand, Assistant Professor of Neurology, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02865018     History of Changes
Other Study ID Numbers: 13-1513
First Posted: August 12, 2016    Key Record Dates
Last Update Posted: August 12, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ilana Katz Sand, Icahn School of Medicine at Mount Sinai:
Neuromyelitis Optica
Cetirizine

Additional relevant MeSH terms:
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Neuromyelitis Optica
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
Cetirizine
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs