Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-01-08 @ 8:16 PM
Study NCT ID:
NCT03217968
Status:
COMPLETED
Last Update Posted:
2018-08-07
First Post:
2017-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Abortive Treatment of Migraine With the Cefaly® Abortive Program Device
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@cefaly.com', 'phone': '+3243676722', 'title': 'Clinical Trial Department director', 'organization': 'CEFALY Technology'}, 'certainAgreement': {'otherDetails': 'The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period of 90 days from the time submitted to the sponsor for review. Sponsor may request:\n\n* deletion of any trade secret, proprietary, or confidential information of Sponsor\n* an additional 90 days to take measures to preserve its Intellectual Property rights', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The data was collected during the 24 hours following the start of the treatment', 'eventGroups': [{'id': 'EG000', 'title': 'Active', 'description': '120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack\n\nCefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS).', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 15, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Burning sensation on the forehead', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'itching/tingling/stinging/numbness sensation on forehead', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in the jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Discomfort in teeth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Drowsiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cold feet', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in eyes', 'notes': 'Severe pain in eyes when eyes open while wearing device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Freedom (PF) at 2 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': '120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack\n\nCefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS).'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 hours', 'description': 'The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to no headache (Grade 0) at 2 hours after the beginning of the e-TNS session.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Most Bothersome Migraine-associated Symptom (MBS) Freedom at 2 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': '120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack\n\nCefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS).'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 hours', 'description': 'The percentage of patients with absence, at 2 hours after the beginning of the e-TNS session, of the most bothersome migraine-associated symptom identified at baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Relief (PR) at 2 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': '120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack\n\nCefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS).'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 hours', 'description': 'The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to a mild headache or to no headache (Grade 1 or 0) at 2 hours after the beginning of the e-TNS session.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Migraine-associated Symptoms Freedom at 2 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': '120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack\n\nCefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS).'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 hours', 'description': 'The percentage of patients with absence of photophobia, phonophobia, nausea and vomiting, at 2 hours after the beginning of the e-TNS session.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Use of Rescue Medication Between 2 and 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': '120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack\n\nCefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS).'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Between 2 and 24 hours', 'description': 'The percentage of patients who took acute anti-migraine medication between 2 and 24 hours after the beginning of the e-TNS session.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sustained Pain Freedom at 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': '120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack\n\nCefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS).'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'description': 'The percentage of patients having no headache (Grade 0) at 2 hours, with no use of rescue medication and no relapse of headache pain within the 24 hours after the beginning of the e-TNS session.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active', 'description': '120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack\n\nCefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Active', 'description': '120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack\n\nCefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS).'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '46.85', 'spread': '10.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '43', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Migraine type', 'classes': [{'title': 'Migraine with aura', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': 'Migraine without aura', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Migraine intensity', 'classes': [{'title': 'Moderate intensity at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}, {'title': 'Severe intensity at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Most bothersome syndrome', 'classes': [{'title': 'Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': 'Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Sensitivity to light', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}, {'title': 'Sensitivity to sound', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-01', 'size': 7334456, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-04-30T03:16', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-09', 'studyFirstSubmitDate': '2017-07-13', 'resultsFirstSubmitDate': '2018-05-04', 'studyFirstSubmitQcDate': '2017-07-13', 'lastUpdatePostDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-05-04', 'studyFirstPostDateStruct': {'date': '2017-07-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2018-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Freedom (PF) at 2 Hours', 'timeFrame': '2 hours', 'description': 'The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to no headache (Grade 0) at 2 hours after the beginning of the e-TNS session.'}, {'measure': 'Most Bothersome Migraine-associated Symptom (MBS) Freedom at 2 Hours', 'timeFrame': '2 hours', 'description': 'The percentage of patients with absence, at 2 hours after the beginning of the e-TNS session, of the most bothersome migraine-associated symptom identified at baseline.'}], 'secondaryOutcomes': [{'measure': 'Pain Relief (PR) at 2 Hours', 'timeFrame': '2 hours', 'description': 'The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to a mild headache or to no headache (Grade 1 or 0) at 2 hours after the beginning of the e-TNS session.'}, {'measure': 'Migraine-associated Symptoms Freedom at 2 Hours', 'timeFrame': '2 hours', 'description': 'The percentage of patients with absence of photophobia, phonophobia, nausea and vomiting, at 2 hours after the beginning of the e-TNS session.'}, {'measure': 'Use of Rescue Medication Between 2 and 24 Hours', 'timeFrame': 'Between 2 and 24 hours', 'description': 'The percentage of patients who took acute anti-migraine medication between 2 and 24 hours after the beginning of the e-TNS session.'}, {'measure': 'Sustained Pain Freedom at 24 Hours', 'timeFrame': '24 hours', 'description': 'The percentage of patients having no headache (Grade 0) at 2 hours, with no use of rescue medication and no relapse of headache pain within the 24 hours after the beginning of the e-TNS session.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Migraine']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the efficacy of the Cefaly® Abortive Program device used at home for 2 hours to treat a migraine attack. This open clinical trial will study the abortive treatment of migraine using the Cefaly® Abortive Program device, prior to development of a sham-controlled trial.', 'detailedDescription': 'The main objective of this study is to have a pilot assessment of the efficacy of the Cefaly® Abortive Program device used at home for 2 hours to treat a migraine attack, as triptans are generally used. That is to say having pilot data to assess the efficacy of the Cefaly® Abortive Program device in the abortive treatment of acute migraine as measured by 2-hour pain freedom, pain relief and migraine associated symptoms freedom, plus evolution of these measurements for 24 hours after the beginning of the treatment session.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 18 to 65 years on the day of signing the informed consent form\n* ≥ 1-year history of migraine with or without aura according to the diagnostic criteria listed in the International Classification of Headache Disorders (ICHD)-III beta (2013) section 1, migraine (8), with the exception of aura without headache, hemiplegic migraine and brainstem aura migraine\n* Migraine onset before the age of 50 years\n* Having between 2 and 8 moderate or severe migraine attacks (Grade 2 or 3) per month in each of the two months prior to screening\n* Patient understands the study procedures, alternative treatments available, and voluntarily agrees to participate in the study by giving written informed consent\n* Patient is able to read and understand the written information (instruction sheet, paper diary and Adverse Events (AE) collecting form)\n\nExclusion Criteria:\n\n* Patient has difficulty distinguishing his/her migraine attacks from tension-type headaches\n* Patient has more than 15 headache days per month\n* Patient having received supraorbital nerve blocks in the prior 4 months\n* Patient having received Botox treatment in the prior 4 months\n* Modification of a migraine prophylaxis treatment in the previous 3 months\n* Diagnosis of other primary headache disorders, except rare (\\< 4) tension-type headaches per month\n* Diagnosis of secondary headache disorders included Medication Overuse Headache\n* Patients abusing opioids or user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence\n* Implanted metallic or electronic device in the head\n* Cardiac pacemaker or implanted or wearable defibrillator\n* Patient having had a previous experience with the Cefaly® device\n* Migraine Aura without headache\n* Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of screening visit (Visit 1)\n* Patients not having the ability to use appropriately the device and/or to perform themselves or bear the first 20-minute stimulation session during the training session at the study site'}, 'identificationModule': {'nctId': 'NCT03217968', 'briefTitle': 'Abortive Treatment of Migraine With the Cefaly® Abortive Program Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cefaly Technology'}, 'officialTitle': 'Abortive Treatment of Migraine With the Cefaly® Abortive Program Device: Pilot Trial', 'orgStudyIdInfo': {'id': '50803'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active', 'description': '120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack', 'interventionNames': ['Device: Cefaly® Abortive Program device']}], 'interventions': [{'name': 'Cefaly® Abortive Program device', 'type': 'DEVICE', 'description': 'The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS).', 'armGroupLabels': ['Active']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14609', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Rochester Clinical Research, Inc.', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Joseph MANN, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rochester Clinical Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cefaly Technology', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}