Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2026-02-19 @ 5:16 AM
Study NCT ID:
NCT02185703
Status:
TERMINATED
Last Update Posted:
2015-08-05
First Post:
2014-07-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chordate System S020 Acute Migraine Clinical Investigation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'whyStopped': 'Too slow recruitment rate', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-03', 'studyFirstSubmitDate': '2014-07-04', 'studyFirstSubmitQcDate': '2014-07-04', 'lastUpdatePostDateStruct': {'date': '2015-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Headache relief', 'timeFrame': '2 hours after treatment initiation', 'description': 'Percentage of subjects with a decrease in migraine headache pain from severe or moderate prior treatment to mild or none at 2 hours after treatment initiation with no use of rescue medication during this time period.'}], 'secondaryOutcomes': [{'measure': 'Pain-free rate', 'timeFrame': '2 hours after treatment initiation', 'description': "Percentage of subjects pain-free (pain intensity rated 'No pain') at 2 hours after treatment initiation with no use of rescue medication."}, {'measure': 'Incidence of recurrence', 'timeFrame': '48 hours after treatment initiation'}, {'measure': '24 hour sustained pain-free rate', 'timeFrame': '24 hours after treatment initiation', 'description': 'percentage of subjects remaining pain-free'}, {'measure': '48 hour sustained pain-free rate', 'timeFrame': '48 hours after treatment initiation', 'description': 'percentage of subjects remaining pain-free'}, {'measure': 'Time to meaningful relief', 'timeFrame': '4 hours post-treatment initiation'}, {'measure': 'Change in nausea, photophobia, phonophobia, vomiting and disability', 'timeFrame': '2 hours post-treatment initiation'}, {'measure': 'Subject global impression', 'timeFrame': '48 hours post-treatment initiation.'}, {'measure': 'Use of rescue medication', 'timeFrame': '48 hours post-treatment initiation'}, {'measure': 'Frequency, severity, device-relationship and outcome of all adverse events', 'timeFrame': '48 hours post-treatment initiation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Migraine']}, 'descriptionModule': {'briefSummary': 'The main purpose of the study is to evaluate the impact of treatment with the Chordate System S020 (medical device) on acute migraine headache pain.', 'detailedDescription': 'One single migraine attack will be treated either with the Chordate System S020 or with Chordate System in placebo mode.\n\nAfter a screening visit, up to 3 months before treatment, eligible subjects will be asked to return to the center at the onset of their next moderate to severe migraine attack. Subjects will be re-checked for eligibility, randomized and treated at the center (treatment visit). The subjects will record their response over the next 48 hours using a diary card. A follow-up visit will be scheduled 3 to 7 days after the treatment. In addition the subjects will be contacted within 24 to 48 hours after treatment initiation via a telephone contact to discuss their health including new or ongoing AEs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with migraine, with or without aura according to International Headache Society (IHS) classification (International Classification of Headache Disorders \\[ICHD\\]-III beta).\n* History of 1 to 6 migraine attacks per month for at least 12 previous months.\n* At least 50% of previous migraine attacks had moderate or severe pain intensity.\n* History of at least 48 hours of freedom from headache between migraine attacks.\n* The majority of the previous untreated migraine attacks lasted at least 8 hours.\n* Migraine onset before the age of 50 years.\n\nExclusion Criteria:\n\n* History (within one year prior to inclusion into this clinical investigation) of 15 or more headache days per month (i.e. headaches of any kind).\n* More than 6 days per month with non-migraine headaches (within one year prior to inclusion into this clinical investigation).\n* Unable to distinguish between migraine headaches and other headache types at the onset of a migraine attack.\n* Treatment with Botox in the head/neck area within 6 months of the screening visit, or between the screening and treatment visit.\n* Previously treated with an implantable stimulator or any implantable devices in the head and/or neck.\n* Pronounced anterior septal nasal deviation.'}, 'identificationModule': {'nctId': 'NCT02185703', 'acronym': 'Amici', 'briefTitle': 'Chordate System S020 Acute Migraine Clinical Investigation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chordate Medical'}, 'officialTitle': 'A Randomized, Placebo-controlled, Double-blind, Multi-center Clinical Investigation to Evaluate the Performance and Safety of the Chordate System When Used in the Treatment of Acute Migraine Attacks of Moderate to Severe Intensity', 'orgStudyIdInfo': {'id': 'PM004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chordate System S020 in treatment mode', 'interventionNames': ['Device: Chordate System S020 in treatment mode']}, {'type': 'SHAM_COMPARATOR', 'label': 'Chordate System S020 in placebo mode', 'interventionNames': ['Device: Chordate System S020 in placebo mode']}], 'interventions': [{'name': 'Chordate System S020 in treatment mode', 'type': 'DEVICE', 'armGroupLabels': ['Chordate System S020 in treatment mode']}, {'name': 'Chordate System S020 in placebo mode', 'type': 'DEVICE', 'armGroupLabels': ['Chordate System S020 in placebo mode']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Universitätsklinikum Tübingen / Zentrum für Neurologie', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': '85435', 'city': 'Erding', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Praxis für Neurologie und Psychiatrie, Psychotherapie, Schmerztherapie', 'geoPoint': {'lat': 48.30603, 'lon': 11.90686}}, {'zip': '80802', 'city': 'München', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Neurologie- & Kopfschmerzzentrum', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}, {'zip': '81377', 'city': 'München', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Klinikum Großhadern / Neurologische Klinik der Universität München', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}, {'zip': '20246', 'city': 'Hamburg', 'state': 'Hamburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '61462', 'city': 'Königstein im Taunus', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Migräne-Klinik Königstein', 'geoPoint': {'lat': 50.17943, 'lon': 8.47132}}, {'zip': '45122', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Universitätsklinikum Essen / Neurologische Klinik', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '41844', 'city': 'Wegberg', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Praxis für spezielle Schmerztherapie', 'geoPoint': {'lat': 51.14221, 'lon': 6.28436}}, {'zip': '10117', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Charité - Universitätsmedizin Berlin / Campus Mitte Klinik für Neurologie', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Hans-Christoph Diener, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Essen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chordate Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}