Trial Outcomes & Findings for Neuromyelitis Optica (NMO) & Cetirizine (NCT NCT02865018)
NCT ID: NCT02865018
Last Updated: 2023-06-07
Results Overview
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.
COMPLETED
PHASE1/PHASE2
16 participants
Baseline and 1 year
2023-06-07
Participant Flow
Twenty-four potential participants were referred by treating physicians at the Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai between April 2014 and February 2015. Sixteen were enrolled between Aprill 2014 and February 2016.
Participant milestones
| Measure |
Cetirizine
10mg oral each day for 1 year
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Cetirizine
10mg oral each day for 1 year
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Neuromyelitis Optica (NMO) & Cetirizine
Baseline characteristics by cohort
| Measure |
Cetirizine
n=16 Participants
10mg oral each day
|
|---|---|
|
Age, Continuous
|
36.5 years
n=93 Participants
|
|
Age, Customized
Age at Symptom onset
|
31.0 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
|
Positive NMO antibody in serum
|
13 Participants
n=93 Participants
|
|
Type of NMO Preventative Treatment at Enrollment
Rituximab
|
8 Participants
n=93 Participants
|
|
Type of NMO Preventative Treatment at Enrollment
Azathioprine
|
1 Participants
n=93 Participants
|
|
Type of NMO Preventative Treatment at Enrollment
Mycophenolate
|
7 Participants
n=93 Participants
|
|
Duration of Current Treatment
|
18.3 months
n=93 Participants
|
|
Number of Previous Preventative NMO treatment types
0
|
10 Participants
n=93 Participants
|
|
Number of Previous Preventative NMO treatment types
1
|
5 Participants
n=93 Participants
|
|
Number of Previous Preventative NMO treatment types
2
|
1 Participants
n=93 Participants
|
|
Oral Prednisone use at Enrollment
|
1 Participants
n=93 Participants
|
|
Total pre-study relapses
|
3.0 relapses
n=93 Participants
|
|
Total pre-study relapses while on current preventative treatment
|
0.0 relapses
n=93 Participants
|
|
Annualized Relapse Rate
|
0.0 relapses per treatment year
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline and 1 yearRelapses 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.
Outcome measures
| Measure |
Cetirizine
n=15 Participants
10mg oral each day for 1 year
|
|---|---|
|
Annualized Relapse Rate Before Cetirizine
Baseline
|
0.4 relapses per year
Standard Deviation 0.80
|
|
Annualized Relapse Rate Before Cetirizine
1 year
|
0.1 relapses per year
Standard Deviation 0.24
|
SECONDARY outcome
Timeframe: Baseline and 1 yearSedation 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.
Outcome measures
| Measure |
Cetirizine
n=15 Participants
10mg oral each day for 1 year
|
|---|---|
|
Epworth Sleepiness Scale
Baseline
|
6.5 units on a scale
Standard Deviation 5.33
|
|
Epworth Sleepiness Scale
1 year
|
6.9 units on a scale
Standard Deviation 4.50
|
SECONDARY outcome
Timeframe: Baseline and 1 yearDisability 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.
Outcome measures
| Measure |
Cetirizine
n=15 Participants
10mg oral each day for 1 year
|
|---|---|
|
Expanded Disability Status Scale (EDSS)
Baseline
|
3.9 units on a scale
Standard Deviation 2.18
|
|
Expanded Disability Status Scale (EDSS)
1 year
|
3.2 units on a scale
Standard Deviation 2.31
|
SECONDARY outcome
Timeframe: 6 monthsEotaxin - an eosinophil-specific chemoattractant in the blood. Immunological measures related to eosinophil activity. Eotaxin plasma levels.
Outcome measures
| Measure |
Cetirizine
n=15 Participants
10mg oral each day for 1 year
|
|---|---|
|
Eotaxin Plasma Levels
|
19.25 pg/mL
Interval 1.44 to 27.75
|
Adverse Events
Cetirizine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cetirizine
n=15 participants at risk
10mg oral each day for 1 year
|
|---|---|
|
Eye disorders
Unilateral eye pain with movement
|
6.7%
1/15
|
|
Eye disorders
Blurry vision with difficulty distinguishing colors
|
6.7%
1/15
|
|
Nervous system disorders
Neuro episode
|
13.3%
2/15
|
Additional Information
Ilana Katz Sand
Icahn School of Medicine at Mount Sinai, Corrine Goldsmith Dickinson Center for MS
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place