Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-01-24 @ 8:25 AM
Study NCT ID:
NCT03185559
Status:
TERMINATED
Last Update Posted:
2018-03-29
First Post:
2017-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized, Double-blind Clinical Investigation to Evaluate the Use of the Relievion™ Device in Treating Migraine.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'whyStopped': 'Investigator retierment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-07-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-01-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-27', 'studyFirstSubmitDate': '2017-06-11', 'studyFirstSubmitQcDate': '2017-06-11', 'lastUpdatePostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Visual Analogue Scale (VAS) Change from basline to 1 hour', 'timeFrame': '1 Hour', 'description': 'Mean change of pain score (measured on a visual analog scale) at 1 hour compared to baseline (if rescue therapy was not used)'}], 'secondaryOutcomes': [{'measure': 'Pain VAS change from baseline to 30 minutes', 'timeFrame': '30 minutes', 'description': 'Mean change of pain score (measured on a visual analog scale) at 30 minutes compared to baseline (if rescue therapy was not used).'}, {'measure': 'Pain VAS change from baseline to 2 hours', 'timeFrame': '2 Hours', 'description': 'Mean change of pain score (measured on a visual analog scale) at 2 hours compared to baseline (if rescue therapy was not used).'}, {'measure': 'Pain VAS change from baseline to 24 hours', 'timeFrame': '24 Hours', 'description': 'Mean change of pain score (measured on a visual analog scale) at 24 hours compared to baseline (if rescue therapy was not used).'}, {'measure': 'Pain VAS change from baseline to 48 hours', 'timeFrame': '48 Hours', 'description': 'Mean change of pain score (measured on a visual analog scale) at 48 hours compared to baseline (if rescue therapy was not used).'}, {'measure': 'Rescue medication at 2 hours', 'timeFrame': '2 hours', 'description': 'Proportion of patients not having required rescue medication at 2 hours'}, {'measure': 'Rescue medication within 24 hours', 'timeFrame': '24 hours', 'description': 'Proportion of patients not having required rescue medication within 24 hours'}, {'measure': 'Rescue medication within 48 hours', 'timeFrame': '48 hours', 'description': 'Proportion of patients not having required rescue medication within 48 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Migraine']}, '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, Relievion™).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* History of episodic or chronic migraine with or without aura meeting the diagnostic criteria listed in ICHD-III (International Classification of Headache Disorders) beta (2013) section 1, migraine, with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, basilar-type migraine, ophthalmoplegic migraine, migrainous infarction).\n* Capable of cooperating with the study protocol and to sign an informed consent.\n\nExclusion Criteria:\n\n* Patients having received Botox treatment in the head region in the prior 4 months.\n* Patients having received supraorbital or occipital nerve blocks in the prior 4 months.\n* History of Medication Overuse Headache.\n* Patients using opioid medication.\n* Allodynia: intolerance to supraorbital and/or occipital neurostimulation (allodynia) that makes the treatment not applicable (the patients will be excluded if they are unable to tolerate the first 3 minutes of neurostimulation).\n* Implanted metal or electrical devices in the head (not including dental implants).\n* Patient having had a previous experience with the Relievion™ device.\n* Patients who have concomitant epilepsy.\n* History of neurosurgical interventions.\n* Patients with implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.\n* History of drug abuse or alcoholism.\n* Participation in current clinical study or participated in a clinical study within 3 months prior to this study.\n* Skin lesion or inflammation at the region of the stimulating electrodes.\n* Personality or somatoform disorder.\n* Pregnancy or Lactation.\n* Women of reproductive age not using efficient contraceptive method.\n* History of cerebrovascular event.\n* Subjects with recent brain or facial trauma (occurred less than 3 months prior to this study)."}, 'identificationModule': {'nctId': 'NCT03185559', 'briefTitle': 'A Randomized, Double-blind Clinical Investigation to Evaluate the Use of the Relievion™ Device in Treating Migraine.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neurolief Ltd.'}, 'officialTitle': 'A Prospective, Randomized, Double-blind, Parallel-group, Sham Controlled Single-center Pivotal Clinical Investigation to Evaluate the Clinical Safety and Performance of Self-administered Home-use Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation Device (Relievion™) in Treating Migraine.', 'orgStudyIdInfo': {'id': 'NRLF-0038-17-MMC-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Relievion device- Treatment stimulation', 'description': 'Relievion Device- Treatment combined occipital and supraorbital transcutaneous nerve stimulation', 'interventionNames': ['Device: Relievion Device- Treatment Stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Relievion device- Sham Stimulation', 'description': 'Relievion Device- Sham combined occipital and supraorbital transcutaneous nerve stimulation', 'interventionNames': ['Device: Relievion Device- Sham stimulation']}], 'interventions': [{'name': 'Relievion Device- Treatment Stimulation', 'type': 'DEVICE', 'otherNames': ['Neurolief device'], 'description': '1 Hour self-administered treatment specific occipital and supraorbital transcutaneous nerve stimulation', 'armGroupLabels': ['Relievion device- Treatment stimulation']}, {'name': 'Relievion Device- Sham stimulation', 'type': 'DEVICE', 'otherNames': ['Sham Neurolief device'], 'description': '1 Hour self-administered sham occipital and supraorbital transcutaneous nerve stimulation', 'armGroupLabels': ['Relievion device- Sham Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kfar Saba', 'country': 'Israel', 'facility': 'Meir General Hospital', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}], 'overallOfficials': [{'name': 'Colin Klein, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Meir Medical Center, Kfar Saba, Israel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neurolief Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}