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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 August 2016 |
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Main ID: |
NCT02865018 |
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Date of registration:
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09/08/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Neuromyelitis Optica (NMO) & Cetirizine
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Scientific title:
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An Open Label, add-on Trial of Cetirizine for Patients With Neuromyelitis Optica |
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Date of first enrolment:
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April 2014 |
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Target sample size:
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16 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02865018 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Ilana Katz Sand, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Icahn School of Medicine at Mount Sinai |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Neuromyelitis Optica
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Intervention(s)
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Drug: cetirizine
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Primary Outcome(s)
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Annualized relapse rate after cetirizine
[Time Frame: 1 year]
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Annualized relapse rate before cetirizine
[Time Frame: Baseline]
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Secondary Outcome(s)
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Epworth Sleepiness Scale
[Time Frame: Baseline]
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Eosinophil counts in the blood
[Time Frame: 6 months]
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Epworth Sleepiness Scale
[Time Frame: 3 months]
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EDSS
[Time Frame: 1 year]
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Eosinophil counts in the blood
[Time Frame: 3 months]
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Eosinophil counts in the blood
[Time Frame: Baseline]
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Epworth Sleepiness Scale
[Time Frame: 6 months]
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Expanded Disability Status Scale (EDSS)
[Time Frame: Baseline]
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Epworth Sleepiness Scale
[Time Frame: 1 year]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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