Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-02-28 @ 5:29 AM
Study NCT ID:
NCT02160535
Status:
TERMINATED
Last Update Posted:
2018-10-23
First Post:
2014-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment of Chronic Post-Traumatic Headache With OnabotulinumtoxinA
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001924', 'term': 'Brain Concussion'}], 'ancestors': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D016489', 'term': 'Head Injuries, Closed'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lucass@uw.edu', 'phone': '206-598-9260', 'title': 'Dr. Sylvia Lucas, MD, PhD', 'organization': 'University of Washington'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Treatment With OnabotulinumtoxinA', 'description': 'OnabotulinumtoxinA\n\nOnabotulinumtoxinA: 155 units of OnabotulinumtoxinA administered intramuscularly. Injections are divided across seven injection specific head/neck muscle areas every 12 weeks to prevent chronic migraine post traumatic headache', 'otherNumAtRisk': 13, 'otherNumAffected': 1, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Increased Headache', 'notes': "One subject experienced increased headache after treatment. Event thought to be local effect from injection sites and subject's sensitization to repetitive needle sticks.", 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Mean Percentage of Headache Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With OnabotulinumtoxinA', 'description': 'OnabotulinumtoxinA\n\nOnabotulinumtoxinA: 155 units of OnabotulinumtoxinA administered intramuscularly. Injections are divided across seven injection specific head/neck muscle areas every 12 weeks to prevent chronic migraine post traumatic headache'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '83', 'spread': '21', 'groupId': 'OG000'}]}]}, {'title': '9 month', 'categories': [{'measurements': [{'value': '49', 'spread': '34', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 9 months', 'description': 'To measure average number of headache days three months after the last onaboltulinumtoxinA injection and compare to average number of headache days during screening month (and present as percentage of headache change).', 'unitOfMeasure': 'percentage of headache days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in SF-36 Assessment Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With OnabotulinumtoxinA', 'description': 'OnabotulinumtoxinA\n\nOnabotulinumtoxinA: 155 units of OnabotulinumtoxinA administered intramuscularly. Injections are divided across seven injection specific head/neck muscle areas every 12 weeks to prevent chronic migraine post traumatic headache'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '47', 'spread': '30', 'groupId': 'OG000'}]}]}, {'title': '9 months', 'categories': [{'measurements': [{'value': '66', 'spread': '29', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 9 month.', 'description': 'Short Form-36 (SF-36) assesses quality of life. Minimum score: 0 Maximum score: 100 Higher values show improvement in quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in MIDAS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With OnabotulinumtoxinA', 'description': 'OnabotulinumtoxinA\n\nOnabotulinumtoxinA: 155 units of OnabotulinumtoxinA administered intramuscularly. Injections are divided across seven injection specific head/neck muscle areas every 12 weeks to prevent chronic migraine post traumatic headache'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '89', 'spread': '51', 'groupId': 'OG000'}]}]}, {'title': '9 months', 'categories': [{'measurements': [{'value': '21', 'spread': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 9 month.', 'description': 'Migraine Disability Assessment Minimum score: 0 Maximum score: 270 Lower values show improvement in disability.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in HIT-6 Score.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With OnabotulinumtoxinA', 'description': 'OnabotulinumtoxinA\n\nOnabotulinumtoxinA: 155 units of OnabotulinumtoxinA administered intramuscularly. Injections are divided across seven injection specific head/neck muscle areas every 12 weeks to prevent chronic migraine post traumatic headache'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '65', 'spread': '4', 'groupId': 'OG000'}]}]}, {'title': '9 months', 'categories': [{'measurements': [{'value': '59', 'spread': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 9 month.', 'description': 'Headache Impact Test-6 Minimum value: 36 Maximum value: 78 Lower values represent less disability.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment With OnabotulinumtoxinA', 'description': 'OnabotulinumtoxinA\n\nOnabotulinumtoxinA: 155 units of OnabotulinumtoxinA administered intramuscularly. Injections are divided across seven injection specific head/neck muscle areas every 12 weeks to prevent chronic migraine post traumatic headache'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment With OnabotulinumtoxinA', 'description': 'OnabotulinumtoxinA\n\nOnabotulinumtoxinA: 155 units of OnabotulinumtoxinA administered intramuscularly. Injections are divided across seven injection specific head/neck muscle areas every 12 weeks to prevent chronic migraine post traumatic headache'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', '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': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'whyStopped': 'Study discontinued due to difficulty in enrolling eligible subjects', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-20', 'studyFirstSubmitDate': '2014-05-15', 'resultsFirstSubmitDate': '2017-10-25', 'studyFirstSubmitQcDate': '2014-06-06', 'lastUpdatePostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-20', 'studyFirstPostDateStruct': {'date': '2014-06-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Mean Percentage of Headache Days', 'timeFrame': 'Baseline, 9 months', 'description': 'To measure average number of headache days three months after the last onaboltulinumtoxinA injection and compare to average number of headache days during screening month (and present as percentage of headache change).'}], 'secondaryOutcomes': [{'measure': 'Change in SF-36 Assessment Scores', 'timeFrame': 'Baseline and 9 month.', 'description': 'Short Form-36 (SF-36) assesses quality of life. Minimum score: 0 Maximum score: 100 Higher values show improvement in quality of life.'}, {'measure': 'Change in MIDAS Score', 'timeFrame': 'Baseline and 9 month.', 'description': 'Migraine Disability Assessment Minimum score: 0 Maximum score: 270 Lower values show improvement in disability.'}, {'measure': 'Change in HIT-6 Score.', 'timeFrame': 'Baseline and 9 month.', 'description': 'Headache Impact Test-6 Minimum value: 36 Maximum value: 78 Lower values represent less disability.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Mild Traumatic Brain Injury', 'Concussion', 'Post Concussive Headache'], 'conditions': ['Chronic Post Traumatic Headache']}, 'descriptionModule': {'briefSummary': 'This study will provide evidence on whether the use of an FDA-approved drug therapy for the treatment of chronic migraine (OnabotulinumtoxinA) shows similar efficacy for treatment of chronic headaches caused by traumatic injury to the brain (TBI) from a direct hit to the head, or a fall, or a motor vehicle accident, or some other traumatic event.', 'detailedDescription': 'Headaches caused by trauma are called post-traumatic headaches (PTH). The Center for Disease Control estimates that between 1.4 and 1.8 million civilians in the US sustain a traumatic brain injury (TBI) each year. The objectives of the study will be evaluated in a civilian population which has sustained a mild Traumatic Brain Injury (mTBI). Research has found that the total cost due to headache in the US workforce is $20 billion per year, most of which is in the form of reduce productivity while at work. For patients with TBI who are already struggling with cognitive and health challenges in an effort to be productive, it seems reasonable to suspect that chronic PTH may slow rehabilitation efforts and successful re-entry into the work force and societal responsibility. Results from this study have the potential to contribute to recommendations for treatment of chronic PTH.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of mild traumatic brain injury (mTBI) within the past 15 months\n* Suffer at least fifteen total headache days per month\n* Ability to speak and read English\n\nExclusion Criteria:\n\n* Subject with hypersensitivity reactions or other intolerance to OnabotulinumtoxinA\n* Previous use of OnabotulinumtoxinA for treatment of headache\n* Any medications commonly used as headache preventives started less than 3 months prior to enrollment\n* Prior or current diagnosis of major psychiatric disorder or other central nervous system disorder\n* Less than 80% compliance (recorded for less than 24 days) in the 30 day screening headache diary\n* Subjects who are pregnant or trying to become pregnant within the timeframe of the study'}, 'identificationModule': {'nctId': 'NCT02160535', 'briefTitle': 'Treatment of Chronic Post-Traumatic Headache With OnabotulinumtoxinA', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Treatment of Chronic Post-Traumatic Headache With OnabotulinumtoxinA', 'orgStudyIdInfo': {'id': '46614'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment with OnabotulinumtoxinA', 'description': 'OnabotulinumtoxinA', 'interventionNames': ['Drug: OnabotulinumtoxinA']}], 'interventions': [{'name': 'OnabotulinumtoxinA', 'type': 'DRUG', 'otherNames': ['BOTOX'], 'description': '155 units of OnabotulinumtoxinA administered intramuscularly. Injections are divided across seven injection specific head/neck muscle areas every 12 weeks to prevent chronic migraine post traumatic headache', 'armGroupLabels': ['Treatment with OnabotulinumtoxinA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Headache Clinic', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Sylvia Lucas, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Sylvia Lucas', 'investigatorAffiliation': 'University of Washington'}}}}