Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2026-02-27 @ 2:21 PM
Study NCT ID:
NCT02865018
Status:
COMPLETED
Last Update Posted:
2023-06-07
First Post:
2016-08-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Neuromyelitis Optica (NMO) & Cetirizine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009471', 'term': 'Neuromyelitis Optica'}], 'ancestors': [{'id': 'D009188', 'term': 'Myelitis, Transverse'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009902', 'term': 'Optic Neuritis'}, {'id': 'D009901', 'term': 'Optic Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017332', 'term': 'Cetirizine'}], 'ancestors': [{'id': 'D006919', 'term': 'Hydroxyzine'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ilana.katzsand@mssm.edu', 'phone': '212-241-6854', 'title': 'Ilana Katz Sand', 'organization': 'Icahn School of Medicine at Mount Sinai, Corrine Goldsmith Dickinson Center for MS'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Small sample size and lack of a control group.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Cetirizine', 'description': '10mg oral each day for 1 year', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 3, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Unilateral eye pain with movement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Blurry vision with difficulty distinguishing colors', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Neuro episode', 'notes': 're-emergence of old symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Annualized Relapse Rate Before Cetirizine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetirizine', 'description': '10mg oral each day for 1 year'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.80', 'groupId': 'OG000'}]}]}, {'title': '1 year', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.24', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 year', 'description': '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.', 'unitOfMeasure': 'relapses per year', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Epworth Sleepiness Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetirizine', 'description': '10mg oral each day for 1 year'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.5', 'spread': '5.33', 'groupId': 'OG000'}]}]}, {'title': '1 year', 'categories': [{'measurements': [{'value': '6.9', 'spread': '4.50', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 year', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Expanded Disability Status Scale (EDSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetirizine', 'description': '10mg oral each day for 1 year'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.9', 'spread': '2.18', 'groupId': 'OG000'}]}]}, {'title': '1 year', 'categories': [{'measurements': [{'value': '3.2', 'spread': '2.31', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 year', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Eotaxin Plasma Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetirizine', 'description': '10mg oral each day for 1 year'}], 'classes': [{'categories': [{'measurements': [{'value': '19.25', 'groupId': 'OG000', 'lowerLimit': '1.44', 'upperLimit': '27.75'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'Eotaxin - an eosinophil-specific chemoattractant in the blood. Immunological measures related to eosinophil activity. Eotaxin plasma levels.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cetirizine', 'description': '10mg oral each day for 1 year'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Cetirizine', 'description': '10mg oral each day'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.5', 'groupId': 'BG000', 'lowerLimit': '27.1', 'upperLimit': '51.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': 'Age at Symptom onset', 'categories': [{'measurements': [{'value': '31.0', 'groupId': 'BG000', 'lowerLimit': '22.5', 'upperLimit': '41.7'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Positive NMO antibody in serum', 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Type of NMO Preventative Treatment at Enrollment', 'classes': [{'title': 'Rituximab', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Azathioprine', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Mycophenolate', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of Current Treatment', 'classes': [{'categories': [{'measurements': [{'value': '18.3', 'groupId': 'BG000', 'lowerLimit': '7.8', 'upperLimit': '40.1'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'months', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Number of Previous Preventative NMO treatment types', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Oral Prednisone use at Enrollment', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Total pre-study relapses', 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'BG000', 'lowerLimit': '1.5', 'upperLimit': '5.0'}]}]}], 'paramType': 'MEDIAN', 'description': 'Relapses were 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."', 'unitOfMeasure': 'relapses', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Total pre-study relapses while on current preventative treatment', 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'BG000', 'lowerLimit': '0.0', 'upperLimit': '1.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'relapses', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Annualized Relapse Rate', 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'BG000', 'lowerLimit': '0.0', 'upperLimit': '0.7'}]}]}], 'paramType': 'MEDIAN', 'description': 'The pre-study annualized relapse rate (ARR) was calculated by taking the number of relapses each participant had experienced after the start of their current reported NMO preventative treatment, divided by the length of time (in years) they had been receiving this treatment.', 'unitOfMeasure': 'relapses per treatment year', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-11', 'studyFirstSubmitDate': '2016-08-09', 'resultsFirstSubmitDate': '2018-01-18', 'studyFirstSubmitQcDate': '2016-08-09', 'lastUpdatePostDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-11', 'studyFirstPostDateStruct': {'date': '2016-08-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Annualized Relapse Rate Before Cetirizine', 'timeFrame': 'Baseline and 1 year', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Epworth Sleepiness Scale', 'timeFrame': 'Baseline and 1 year', 'description': '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.'}, {'measure': 'Expanded Disability Status Scale (EDSS)', 'timeFrame': 'Baseline and 1 year', 'description': '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.'}, {'measure': 'Eotaxin Plasma Levels', 'timeFrame': '6 months', 'description': 'Eotaxin - an eosinophil-specific chemoattractant in the blood. Immunological measures related to eosinophil activity. Eotaxin plasma levels.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Neuromyelitis Optica', 'Cetirizine'], 'conditions': ['Neuromyelitis Optica']}, 'descriptionModule': {'briefSummary': "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).\n\nNMO 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.\n\nUntil 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.\n\nCetirizine 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.", 'detailedDescription': '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.\n\nMedication compliance will be assessed by the research coordinator at each visit through discussion with the patient and pill counting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years to 85\n* 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.\n* Disease duration of at least 6 months\n* Stable, without any NMO relapses, for the 3 months prior to the baseline assessment visit\n* 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.\n\nExclusion Criteria:\n\n* Current therapy with daily cetirizine or another daily antihistamine for any indication\n* Known hypersensitivity to cetirizine, hydroxyzine, or any component of the formulation\n* Change in NMO disease-modifying therapy in the 3 months prior to baseline assessment\n* Pregnancy or planning pregnancy during the study period\n* Severe renal or hepatic impairment\n* Inability to complete the study protocol for any reason'}, 'identificationModule': {'nctId': 'NCT02865018', 'briefTitle': 'Neuromyelitis Optica (NMO) & Cetirizine', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'An Open Label, add-on Trial of Cetirizine for Patients With Neuromyelitis Optica', 'orgStudyIdInfo': {'id': '13-1513'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cetirizine', 'description': '10mg oral each day', 'interventionNames': ['Drug: cetirizine']}], 'interventions': [{'name': 'cetirizine', 'type': 'DRUG', 'otherNames': ['Zyrtec'], 'armGroupLabels': ['cetirizine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Ilana Katz Sand, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'collaborators': [{'name': 'Guthy Jackson Charitable Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Neurology', 'investigatorFullName': 'Ilana Katz Sand', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}