Trial · NCT02865018
Neuromyelitis Optica (NMO) & Cetirizine
NCT02865018, Phase 1, Phase 2, Completed, Icahn School of Medicine at Mount Sinai; results first posted 2023-06-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Neuromyelitis Optica (NMO) & Cetirizine. Trials, record NCT02865018. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02865018
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Neuromyelitis Optica (NMO) & Cetirizine
- NCT number
- NCT02865018
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 16 participants, actual
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Conditions
- Neuromyelitis Optica
- Interventions
- cetirizine
- First posted
- 2016-08-12
- Last updated
- 2023-06-07
- Results first posted
- 2023-06-07
- Limitations and caveats
- Small sample size and lack of a control group.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Annualized Relapse Rate Before Cetirizine | Baseline and 1 year | 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. |
| Secondary | Epworth Sleepiness Scale | Baseline and 1 year | 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. |
| Secondary | Expanded Disability Status Scale (EDSS) | Baseline and 1 year | 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, 10, being death due to MS. |
| Secondary | Eotaxin Plasma Levels | 6 months | Eotaxin - an eosinophil-specific chemoattractant in the blood. Immunological measures related to eosinophil activity. Eotaxin plasma levels. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Annualized Relapse Rate Before Cetirizine | Baseline and 1 year | relapses per year | MEAN | |
| SECONDARY | Epworth Sleepiness Scale | Baseline and 1 year | units on a scale | MEAN | |
| SECONDARY | Expanded Disability Status Scale (EDSS) | Baseline and 1 year | units on a scale | MEAN | |
| SECONDARY | Eotaxin Plasma Levels | 6 months | pg/mL | MEDIAN |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Annualized Relapse Rate Before Cetirizine | Cetirizine | Baseline | 0.4 | Standard Deviation 0.80 | relapses per year |
| Annualized Relapse Rate Before Cetirizine | Cetirizine | 1 year | 0.1 | Standard Deviation 0.24 | relapses per year |
| Epworth Sleepiness Scale | Cetirizine | Baseline | 6.5 | Standard Deviation 5.33 | units on a scale |
| Epworth Sleepiness Scale | Cetirizine | 1 year | 6.9 | Standard Deviation 4.50 | units on a scale |
| Expanded Disability Status Scale (EDSS) | Cetirizine | Baseline | 3.9 | Standard Deviation 2.18 | units on a scale |
| Expanded Disability Status Scale (EDSS) | Cetirizine | 1 year | 3.2 | Standard Deviation 2.31 | units on a scale |
| Eotaxin Plasma Levels | Cetirizine | 19.25 | Inter-Quartile Range 1.44 to 27.75 | pg/mL |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cetirizine | 16 | |
| Overall Study | COMPLETED | Cetirizine | 15 | |
| Overall Study | NOT COMPLETED | Cetirizine | 1 |
Source ClinicalTrials.gov
Adverse events3
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Unilateral eye pain with movement | Eye disorders | Cetirizine | 1 | 15 | |
| other | Blurry vision with difficulty distinguishing colors | Eye disorders | Cetirizine | 1 | 15 | |
| other | Neuro episode | Nervous system disorders | Cetirizine | 2 | 15 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cetirizine | 0 | 15 |
| Total, other adverse events | Cetirizine | 3 | 15 |
| Total, serious adverse events | Cetirizine | 0 | 15 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02865018
GET https://conductscience.org/api/trials/v1/NCT02865018/registered