Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2026-02-28 @ 12:03 AM
Study NCT ID:
NCT03631550
Status:
COMPLETED
Last Update Posted:
2022-09-22
First Post:
2018-08-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The RIME Study - Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'michal.kedar-datel@neurolief.com', 'phone': '+972-52-6659806', 'title': 'Michal Kedar-Datel', 'organization': 'Neurolief Ltd.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events data were collected per study participant from Enrollment (randomization) through study exit. ie 70 days', 'description': 'Adverse events related or unrelated to the study device and/or procedure were collected per study participant from Enrollment (randomization) through study exit. The ITT data analysis set served as the principal data analysis set for the safety analyses.', 'eventGroups': [{'id': 'EG000', 'title': 'Active', 'description': 'Relivion Active device\n\nRelivion active: 1 hour self-administered occipital and supraorbital transcutaneous nerve stimulation', 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 8, 'seriousNumAtRisk': 67, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham', 'description': 'Relivion Sham device\n\nRelivion Sham: 1 hour self-administered Sham occipital and supraorbital transcutaneous nerve stimulation', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 2, 'seriousNumAtRisk': 64, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Unpleasant sensation during treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Scalp numbness sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tingling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Twitching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'COVID', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'inner ear scratch', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'lip numbness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pressure/discomfort of head', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Subjects Reporting Reduction of Migraine Headache Pain at 2 Hours From Treatment Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': 'Relivion Active device\n\nRelivion active: 1 hour self-administered occipital and supraorbital transcutaneous nerve stimulation'}, {'id': 'OG001', 'title': 'Sham', 'description': 'Relivion Sham device\n\nRelivion Sham: 1 hour self-administered Sham occipital and supraorbital transcutaneous nerve stimulation'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.018', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 hours from treatment initiation', 'description': 'the number and percent of subjects reporting reduction of migraine headache pain 2 hours post treatment initiation from severe or moderate to mild or no pain, or from mild to no pain, in their first eligible treated migraine attack (if rescue therapy was not used)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT present the number and percentage of subjects with pain relief (reduction in pain level) 2 hours post-treatment, from severe or moderate to mild or no pain, or from mild to no pain, in their first eligible treated episode. If a subject had used rescue medication up to the assessment time point, he/she was considered as not reaching the endpoint. mITT set included 50 patients in the Active arm and 59 patients in the sham arm'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects Reporting Improvement in Their Most Bothersome Symptom (MBS) Other Than a Headache, 2 Hours Post-treatment Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': 'Relivion Active device\n\nRelivion active: 1 hour self-administered occipital and supraorbital transcutaneous nerve stimulation'}, {'id': 'OG001', 'title': 'Sham', 'description': 'Relivion Sham device\n\nRelivion Sham: 1 hour self-administered Sham occipital and supraorbital transcutaneous nerve stimulation'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0466', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 hours from treatment initiation', 'description': 'The number and percentage of subjects reporting improvement in their Most Bothersome Symptom (MBS) other than a headache, 2 hours post-treatment initiation (if rescue therapy was not used), in their first eligible treated migraine attack. MBS may be nausea, photophobia, phonophobia', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population analysis. mITT set included 50 patients in the Active arm from which 36 reported MBS and 59 patients in the sham arm from which 45 reported MBS'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects Reporting Reduction of Migraine Headache Pain 1-hour Post Treatment Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': 'Relivion Active device\n\nRelivion active: 1 hour self-administered occipital and supraorbital transcutaneous nerve stimulation'}, {'id': 'OG001', 'title': 'Sham', 'description': 'Relivion Sham device\n\nRelivion Sham: 1 hour self-administered Sham occipital and supraorbital transcutaneous nerve stimulation'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0677', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 hour from treatment initiation', 'description': 'The number and percentage of subjects reporting reduction of migraine headache pain 1-hour post treatment initiation (if rescue therapy was not used), from severe or moderate to mild or no pain, or from mild to no pain, in their first eligible treated migraine attack', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population analysis. mITT set included 50 patients in the Active arm and 59 patients in the sham arm'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects Who Are Pain Free at 2 Hours Post Treatment Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': 'Relivion Active device\n\nRelivion active: 1 hour self-administered occipital and supraorbital transcutaneous nerve stimulation'}, {'id': 'OG001', 'title': 'Sham', 'description': 'Relivion Sham device\n\nRelivion Sham: 1 hour self-administered Sham occipital and supraorbital transcutaneous nerve stimulation'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 hours from treatment initiation', 'description': 'The number and percentage of subjects who are pain free at 2 hours post treatment initiation (if rescue therapy was not used), in their first eligible treated migraine attack', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population anaylsis. mITT set included 50 patients in the Active arm and 59 patients in the sham arm'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': 'Relivion Active device\n\nRelivion active: 1 hour self-administered occipital and supraorbital transcutaneous nerve stimulation'}, {'id': 'OG001', 'title': 'Sham', 'description': 'Relivion Sham device\n\nRelivion Sham: 1 hour self-administered Sham occipital and supraorbital transcutaneous nerve stimulation'}], 'classes': [{'title': 'Participants with Adverse Events', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Participants with device related Adverse Events', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0968', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Enrollment (randomization) through study exit i.e. 70 days', 'description': 'Safety of the study device following study treatment: Number and Rate of participates with Adverse events related or unrelated to the study device', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population analysis'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'The Change in Pseudo-continuous Pain Score From Baseline to 1-hour Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': 'Relivion Active device\n\nRelivion active: 1 hour self-administered occipital and supraorbital transcutaneous nerve stimulation'}, {'id': 'OG001', 'title': 'Sham', 'description': 'Relivion Sham device\n\nRelivion Sham: 1 hour self-administered Sham occipital and supraorbital transcutaneous nerve stimulation'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.637', 'groupId': 'OG000', 'lowerLimit': '-0.881', 'upperLimit': '-0.392'}, {'value': '-0.306', 'groupId': 'OG001', 'lowerLimit': '-0.537', 'upperLimit': '-0.075'}]}]}], 'analyses': [{'pValue': '0.0121', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 1-hour post treatment', 'description': 'as per the Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency" June 2020 FDA Guidance, which states that a modifications to the definition and ascertainment of trial endpoints may be warranted to address the impact of COVID-19. A potential modification for a binary endpoint that is based on a continuous or ordinal measurement is by using the continuous or ordinal measurement as the endpoint. therefore, an additional analysis to the study end points , the migraine headache pain level was transformed into a numerical score (pseudo-continuous): "No pain"=0, "Mild"=1, "Moderate"=2, "Severe"=3. If rescue medication was used, the score after the rescue intake post-treatment are set to the baseline value. The change from baseline is compared between the study arms with an analysis of covariance model adjusted for site and baseline pain level.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT set included 50 patients in the Active arm and 59 patients in the sham arm'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active', 'description': 'Relivion Active device\n\nRelivion active: 1 hour self-administered occipital and supraorbital transcutaneous nerve stimulation'}, {'id': 'FG001', 'title': 'Sham', 'description': 'Relivion Sham device\n\nRelivion Sham: 1 hour self-administered Sham occipital and supraorbital transcutaneous nerve stimulation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Full Analysis set (FA) include all the subjects randomized, including the subjects treated with the device up to May 31, 2019', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '93'}]}, {'type': 'The ITT Analysis Set', 'comment': 'The Intent to Treat (ITT) analysis set which includes all randomized subjects who were treated with the device after May 31, 2019 (including self-practice). Per ITT principles, all subjects were analyzed as randomized.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'The mITT Analysis Set', 'comment': 'The mITT analysis set which includes all subjects from the ITT analysis set who treat at least one eligible attack (excluding the "self-practice test") analyzed as treated.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'comment': 'from FA set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '29'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active', 'description': 'Relivion Active device\n\nRelivion active: 1 hour self-administered occipital and supraorbital transcutaneous nerve stimulation'}, {'id': 'BG001', 'title': 'Sham', 'description': 'Relivion Sham device\n\nRelivion Sham: 1 hour self-administered Sham occipital and supraorbital transcutaneous nerve stimulation'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.7', 'spread': '12.47', 'groupId': 'BG000'}, {'value': '39.9', 'spread': '13.03', 'groupId': 'BG001'}, {'value': '40.3', 'spread': '12.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-11', 'size': 783013, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-04-14T02:13', 'hasProtocol': True}, {'date': '2020-08-31', 'size': 279310, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-04-14T02:14', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 187}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-01', 'studyFirstSubmitDate': '2018-08-13', 'resultsFirstSubmitDate': '2022-05-23', 'studyFirstSubmitQcDate': '2018-08-14', 'lastUpdatePostDateStruct': {'date': '2022-09-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-06-16', 'studyFirstPostDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'From Enrollment (randomization) through study exit i.e. 70 days', 'description': 'Safety of the study device following study treatment: Number and Rate of participates with Adverse events related or unrelated to the study device'}, {'measure': 'The Change in Pseudo-continuous Pain Score From Baseline to 1-hour Post Treatment', 'timeFrame': 'baseline to 1-hour post treatment', 'description': 'as per the Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency" June 2020 FDA Guidance, which states that a modifications to the definition and ascertainment of trial endpoints may be warranted to address the impact of COVID-19. A potential modification for a binary endpoint that is based on a continuous or ordinal measurement is by using the continuous or ordinal measurement as the endpoint. therefore, an additional analysis to the study end points , the migraine headache pain level was transformed into a numerical score (pseudo-continuous): "No pain"=0, "Mild"=1, "Moderate"=2, "Severe"=3. If rescue medication was used, the score after the rescue intake post-treatment are set to the baseline value. The change from baseline is compared between the study arms with an analysis of covariance model adjusted for site and baseline pain level.'}], 'primaryOutcomes': [{'measure': 'Proportion of Subjects Reporting Reduction of Migraine Headache Pain at 2 Hours From Treatment Initiation', 'timeFrame': '2 hours from treatment initiation', 'description': 'the number and percent of subjects reporting reduction of migraine headache pain 2 hours post treatment initiation from severe or moderate to mild or no pain, or from mild to no pain, in their first eligible treated migraine attack (if rescue therapy was not used)'}], 'secondaryOutcomes': [{'measure': 'Proportion of Subjects Reporting Improvement in Their Most Bothersome Symptom (MBS) Other Than a Headache, 2 Hours Post-treatment Initiation', 'timeFrame': '2 hours from treatment initiation', 'description': 'The number and percentage of subjects reporting improvement in their Most Bothersome Symptom (MBS) other than a headache, 2 hours post-treatment initiation (if rescue therapy was not used), in their first eligible treated migraine attack. MBS may be nausea, photophobia, phonophobia'}, {'measure': 'Proportion of Subjects Reporting Reduction of Migraine Headache Pain 1-hour Post Treatment Initiation', 'timeFrame': '1 hour from treatment initiation', 'description': 'The number and percentage of subjects reporting reduction of migraine headache pain 1-hour post treatment initiation (if rescue therapy was not used), from severe or moderate to mild or no pain, or from mild to no pain, in their first eligible treated migraine attack'}, {'measure': 'Proportion of Subjects Who Are Pain Free at 2 Hours Post Treatment Initiation', 'timeFrame': '2 hours from treatment initiation', 'description': 'The number and percentage of subjects who are pain free at 2 hours post treatment initiation (if rescue therapy was not used), in their first eligible treated migraine attack'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Acute Migraine']}, 'referencesModule': {'references': [{'pmid': '35748757', 'type': 'DERIVED', 'citation': 'Tepper SJ, Grosberg B, Daniel O, Kuruvilla DE, Vainstein G, Deutsch L, Sharon R. Migraine treatment with external concurrent occipital and trigeminal neurostimulation-A randomized controlled trial. Headache. 2022 Sep;62(8):989-1001. doi: 10.1111/head.14350. Epub 2022 Jun 24.'}]}, 'descriptionModule': {'briefSummary': 'this study will evaluate the clinical performance and safety of a self administered abortive treatment for migraine headache using combined occipital and supraorbital transcutaneous nerve stimulator (Neurolief device, Relivion®)', 'detailedDescription': 'The Relivion® is a non-invasive transcutaneous neuro-stimulator is indicated for the acute treatment of migraine with or without aura in subjects 18 years of age or older. The Relivion® is intended to be a prescription device, self-used at home.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects 18 years of age and older.\n2. Subject meets the ICHD (International Classification of Headache Disorders)-3 (2018) diagnostic criteria for Migraine with or without aura.\n3. Subject reports 1-6 Migraine attacks per month; other headaches no more than 6 days per month.\n4. Subject is willing to and capable of complying with the specified study requirements, provided written Informed Consent, can complete the electronic diaries, and can be contacted by telephone.\n\nExclusion Criteria:\n\n1. Subject having received Botox treatment in the head region in the prior 3 months.\n2. Subject having received supraorbital or occipital nerve blocks in the prior month.\n3. Past 6 months of chronic migraine, New Daily Persistent Headache, and chronic tension-type headache per ICHD-3 (2018) diagnostic criteria.\n4. Current medication overuse headache.\n5. Use of opioid medications in the prior 1 month.\n6. Use of barbiturates in the prior 1 month.\n7. Subject has \\>10 headache days per month\n8. Implanted metal/shrapnel or electrical devices in the head (not including dental implants), a cardiac pacemaker or an implanted or wearable defibrillator.\n9. Received parenteral infusions for migraine within the previous 2 weeks.\n10. Subject has known uncontrolled epilepsy.\n11. History of neurosurgical interventions\n12. Subject with implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.\n13. Current drug abuse or alcoholism.\n14. Subject is participating in any other clinical study.\n15. Skin lesion or inflammation at the region of the stimulating electrodes.\n16. Personality or somatoform disorder.\n17. Pregnancy or Lactation.\n18. Women with child bearing potential without medically acceptable method of contraception (NOTE: Females of child bearing potential must have a negative pregnancy test).\n19. Documented history of cerebrovascular event.\n20. Subject with recent brain or facial trauma (occurred less than 3 months prior to this study).\n21. Subject participated in a previous study with the Relivion device.\n22. The subject does not have the basic cognitive and motor skills needed to operate a smartphone.\n23. Subject with head circumference smaller than 51 centimeters or head circumference larger than 60 centimeters\n24. Subject with other significant pain problem that in the opinion of the investigator may confound the study assessments.'}, 'identificationModule': {'nctId': 'NCT03631550', 'briefTitle': 'The RIME Study - Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of Migraine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neurolief Ltd.'}, 'officialTitle': 'The RIME Study - Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of Migraine', 'orgStudyIdInfo': {'id': 'SP-302 RIME'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active', 'description': 'Relivion Active device', 'interventionNames': ['Device: Relivion active']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham', 'description': 'Relivion Sham device', 'interventionNames': ['Device: Relivion Sham']}], 'interventions': [{'name': 'Relivion active', 'type': 'DEVICE', 'description': '1 hour self-administered occipital and supraorbital transcutaneous nerve stimulation', 'armGroupLabels': ['Active']}, {'name': 'Relivion Sham', 'type': 'DEVICE', 'description': '1 hour self-administered Sham occipital and supraorbital transcutaneous nerve stimulation', 'armGroupLabels': ['Sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85283', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Clinical Research Consortium, an AMR company', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '06107', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hartford HealthCare Headache Center', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '02760', 'city': 'North Attleboro', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Regeneris Medical', 'geoPoint': {'lat': 41.98343, 'lon': -71.33283}}, {'zip': '89119', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Clinical Research Consortium, an AMR company', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth-Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'city': 'Ashkelon', 'country': 'Israel', 'facility': 'Barzilai MC', 'geoPoint': {'lat': 31.66926, 'lon': 34.57149}}, {'city': 'Hadera', 'country': 'Israel', 'facility': 'Hillel Yaffe Medical Center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}, {'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Sharei Zedek MC', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'city': 'Kfar Saba', 'country': 'Israel', 'facility': 'Macabi healtcenter services', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}, {'city': 'Netanya', 'country': 'Israel', 'facility': 'Laniado MC', 'geoPoint': {'lat': 32.33291, 'lon': 34.85992}}, {'city': 'Raanana', 'country': 'Israel', 'facility': 'Macabi healtcenter services', 'geoPoint': {'lat': 32.1836, 'lon': 34.87386}}], 'overallOfficials': [{'name': 'stewart J. Tepper, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neurolief Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}