Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-25 @ 5:01 AM
NCT ID:
NCT02865018
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02865018
Study Brief:
Protocol Section:
NCT02865018