{"protocolSection":{"identificationModule":{"nctId":"NCT02090998","orgStudyIdInfo":{"id":"2012002610"},"organization":{"fullName":"Rutgers, The State University of New Jersey","class":"OTHER"},"briefTitle":"Sphenopalatine Ganglion Nerve Block vs. Elavil for Treatment of Transformed Migraines","officialTitle":"A Comparison of the Efficacy of 5% Lidocaine Anesthetic to Provide SPGB Vs. Elavil for the Treatment of Transformed Migraine"},"statusModule":{"statusVerifiedDate":"2023-05","overallStatus":"TERMINATED","whyStopped":"no patients during covid pandemic","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2014-05"},"primaryCompletionDateStruct":{"date":"2020-03-16","type":"ACTUAL"},"completionDateStruct":{"date":"2020-03-16","type":"ACTUAL"},"studyFirstSubmitDate":"2014-03-17","studyFirstSubmitQcDate":"2014-03-18","studyFirstPostDateStruct":{"date":"2014-03-19","type":"ESTIMATED"},"resultsFirstSubmitDate":"2021-07-02","resultsFirstSubmitQcDate":"2021-11-30","resultsFirstPostDateStruct":{"date":"2021-12-29","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-05-27","lastUpdatePostDateStruct":{"date":"2026-06-23","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"William Grubb, M.D.","investigatorTitle":"Associate Prof.","investigatorAffiliation":"Rutgers, The State University of New Jersey"},"leadSponsor":{"name":"Rutgers, The State University of New Jersey","class":"OTHER"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This study will compare a local anesthetic technique that has been used to treat subjects suffering from transformed migraines (chronic migraines) versus medical management with traditional antidepressant Amitriptyline / Elavil.\n\nSubjects will be randomized into one of two treatment groups to compare the safety and efficacy of the therapies. Subjects will recieve either sphenopalatine ganglion nerve block with 5% lidocaine gel into the nasopharynx or medical management with traditional antidepressants, Elavil, to produce a reduction in the frequency and severity of the headache.\n\nWe propose that there will be a difference in the outcomes when comparing the two methods of treating transformed migraines and that one research arm will result in more patient satisfaction and greater efficacy in the treatment of subjects","detailedDescription":"Arm one will receive Sphenopalatine Ganglion Nerve Block weekly for 4 weeks\n\nArm two will receive Amitriptyline / Elavil daily for 30 Days"},"conditionsModule":{"conditions":["Transformed Migraine","Chronic Daily Headache"],"keywords":["Migraine Headache","Menstrual Migraine","Vascular Headache","Temporal Lobe Seizure"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"PREVENTION","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":10,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"SPG Nerve Block with Lidocaine 5% gel","type":"ACTIVE_COMPARATOR","description":"Sphenopalatine Ganglion Nerve Block (SPG Nerve Block) will be administed weekly for 4 weeks using 5% Lidocaine gel This intervention (a nerve block) will treat the headache for the time period investigated","interventionNames":["Procedure: SPG Block with 5% Lidocaine gel","Drug: Amitriptyline"]},{"label":"Amitriptyline / Elavil","type":"ACTIVE_COMPARATOR","description":"Amitriptyline / Elavil 10 mg once a day for one week then Amitriotyline 20 mg once a day for three weeks This intervention will treat the headache for the time period investigated","interventionNames":["Procedure: SPG Block with 5% Lidocaine gel","Drug: Amitriptyline"]}],"interventions":[{"type":"PROCEDURE","name":"SPG Block with 5% Lidocaine gel","description":"cotten tipped applicators are with 5% lidocaine gel and placed in the nares to lye in the skin over the sphenopalitine ganglion. The applcator is use to saturate the spenopalitine ganglion with 5ml of 1% lidocaine local anesthesia","armGroupLabels":["Amitriptyline / Elavil","SPG Nerve Block with Lidocaine 5% gel"]},{"type":"DRUG","name":"Amitriptyline","description":"The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days","armGroupLabels":["Amitriptyline / Elavil","SPG Nerve Block with Lidocaine 5% gel"],"otherNames":["Elavil"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Daily Headaches","description":"The number of times per day that symptoms occur","timeFrame":"Study Day 1 through Study Day 30"}],"otherOutcomes":[{"measure":"Duration of Inactivity Associated With Headaches","description":"The time after events that effects patient activity level","timeFrame":"Study Day 1 thorugh Study Day 30"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n1. Male and female age 18-90\n2. Subject have formal medical diagnosis of migraine headache\n3. Subjects currently require treatment for headache\n4. Subjects who have received optimal medical management from migraines including triptans (Imitrex, Amerge and Relpax)\n5. Subjects who have recieved optimal medical management for migraines including anticonvulsants (Depakote, Lamictal, klonopin\n\nExclusion Criteria:\n\n1. Less than 18 years of age\n2. Subjects will be excluded if they are already being treated with lidocaine (patch or other vehicle) for chronic pain\n3. Untreated Heart Failure\n4. Pregnancy\n5. Individuals unwilling to comply with study procedures and follow-up","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"Rutgers, Robert Wood Johnson Medical School , Pain Center of NJ","city":"New Brunswick","state":"New Jersey","zip":"08901","country":"United States","geoPoint":{"lat":40.48622,"lon":-74.45182}}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Amitriptyline / Elavil","description":"Amitriptyline / Elavil 10 mg once a day for one week then Amitriotyline 20 mg once a day for three weeks This intervention will treat the headache for the time period investigated\n\nSPG Block with 5% Lidocaine gel: cotten tipped applicators are with 5% lidocaine gel and placed in the nares to lye in the skin over the sphenopalitine ganglion. The applcator is use to saturate the spenopalitine ganglion with 5ml of 1% lidocaine local anesthesia\n\nAmitriptyline: The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days"},{"id":"FG001","title":"SPG Nerve Block With Lidocaine 5% Gel","description":"Sphenopalatine Ganglion Nerve Block (SPG Nerve Block) will be administed weekly for 4 weeks using 5% Lidocaine gel This intervention (a nerve block) will treat the headache for the time period investigated\n\nSPG Block with 5% Lidocaine gel: cotten tipped applicators are with 5% lidocaine gel and placed in the nares to lye in the skin over the sphenopalitine ganglion. The applcator is use to saturate the spenopalitine ganglion with 5ml of 1% lidocaine local anesthesia\n\nAmitriptyline: The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"8"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"8"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Amitriptyline / Elavil","description":"Amitriptyline / Elavil 10 mg once a day for one week then Amitriotyline 20 mg once a day for three weeks This intervention will treat the headache for the time period investigated\n\nSPG Block with 5% Lidocaine gel: cotten tipped applicators are with 5% lidocaine gel and placed in the nares to lye in the skin over the sphenopalitine ganglion. The applcator is use to saturate the spenopalitine ganglion with 5ml of 1% lidocaine local anesthesia\n\nAmitriptyline: The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days"},{"id":"BG001","title":"SPG Nerve Block With Lidocaine 5% Gel","description":"Sphenopalatine Ganglion Nerve Block (SPG Nerve Block) will be administed weekly for 4 weeks using 5% Lidocaine gel This intervention (a nerve block) will treat the headache for the time period investigated\n\nSPG Block with 5% Lidocaine gel: cotten tipped applicators are with 5% lidocaine gel and placed in the nares to lye in the skin over the sphenopalitine ganglion. The applcator is use to saturate the spenopalitine ganglion with 5ml of 1% lidocaine local anesthesia\n\nAmitriptyline: The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"10"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"10"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"FULL_RANGE","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"46","lowerLimit":"45","upperLimit":"48"},{"groupId":"BG001","value":"59","lowerLimit":"39","upperLimit":"84"},{"groupId":"BG002","value":"56","lowerLimit":"39","upperLimit":"84"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"7"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"3"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"10"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"9"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"10"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Daily Headaches","description":"The number of times per day that symptoms occur","populationDescription":"participants from 18-82 who had failed conventional headache therapies","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Number of Daily Headaches","timeFrame":"Study Day 1 through Study Day 30","groups":[{"id":"OG000","title":"Amitriptyline / Elavil","description":"Amitriptyline / Elavil 10 mg once a day for one week then Amitriotyline 20 mg once a day for three weeks This intervention will treat the headache for the time period investigated SPG Block with 5% Lidocaine gel: cotten tipped applicators are with 5% lidocaine gel and placed in the nares to lye in the skin over the sphenopalitine ganglion. The applcator is use to saturate the spenopalitine ganglion with 5ml of 1% lidocaine local anesthesia\n\nAmitriptyline: The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days"},{"id":"OG001","title":"SPG Nerve Block With Lidocaine 5% Gel","description":"Sphenopalatine Ganglion Nerve Block (SPG Nerve Block) will be administed weekly for 4 weeks using 5% Lidocaine gel This intervention (a nerve block) will treat the headache for the time period investigated\n\nSPG Block with 5% Lidocaine gel: cotten tipped applicators are with 5% lidocaine gel and placed in the nares to lye in the skin over the sphenopalitine ganglion. The applcator is use to saturate the spenopalitine ganglion with 5ml of 1% lidocaine local anesthesia\n\nAmitriptyline: The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"20.5","spread":"0.5"},{"groupId":"OG001","value":"13.4","spread":"10.4"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Duration of Inactivity Associated With Headaches","description":"The time after events that effects patient activity level","reportingStatus":"NOT_POSTED","timeFrame":"Study Day 1 thorugh Study Day 30","denomUnitsSelected":"Participants"}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"3 months","eventGroups":[{"id":"EG000","title":"Amitriptyline / Elavil","description":"Amitriptyline / Elavil 10 mg once a day for one week then Amitriotyline 20 mg once a day for three weeks This intervention will treat the headache for the time period investigated\n\nSPG Block with 5% Lidocaine gel: cotten tipped applicators are with 5% lidocaine gel and placed in the nares to lye in the skin over the sphenopalitine ganglion. The applcator is use to saturate the spenopalitine ganglion with 5ml of 1% lidocaine local anesthesia\n\nAmitriptyline: The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days","deathsNumAffected":0,"deathsNumAtRisk":2,"seriousNumAffected":0,"seriousNumAtRisk":2,"otherNumAffected":0,"otherNumAtRisk":2},{"id":"EG001","title":"SPG Nerve Block With Lidocaine 5% Gel","description":"Sphenopalatine Ganglion Nerve Block (SPG Nerve Block) will be administed weekly for 4 weeks using 5% Lidocaine gel This intervention (a nerve block) will treat the headache for the time period investigated\n\nSPG Block with 5% Lidocaine gel: cotten tipped applicators are with 5% lidocaine gel and placed in the nares to lye in the skin over the sphenopalitine ganglion. The applcator is use to saturate the spenopalitine ganglion with 5ml of 1% lidocaine local anesthesia\n\nAmitriptyline: The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days","deathsNumAffected":0,"deathsNumAtRisk":8,"seriousNumAffected":0,"seriousNumAtRisk":8,"otherNumAffected":0,"otherNumAtRisk":8}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"william grubb md","organization":"Rutgers/RWJMS","email":"grubbwr@rwjms.rutgers.edu","phone":"7322357827"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot_SAP","hasProtocol":true,"hasSap":true,"hasIcf":false,"label":"Study Protocol and Statistical Analysis Plan","date":"2021-08-03","uploadDate":"2021-08-31T09:18","filename":"Prot_SAP_000.pdf","size":336319},{"typeAbbrev":"ICF","hasProtocol":false,"hasSap":false,"hasIcf":true,"label":"Informed Consent Form","date":"2021-08-03","uploadDate":"2021-10-18T12:46","filename":"ICF_001.pdf","size":502709}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D020773","term":"Headache Disorders"},{"id":"D008881","term":"Migraine Disorders"},{"id":"D014653","term":"Vascular Headaches"},{"id":"D004833","term":"Epilepsy, Temporal Lobe"}],"ancestors":[{"id":"D001927","term":"Brain Diseases"},{"id":"D002493","term":"Central Nervous System Diseases"},{"id":"D009422","term":"Nervous System Diseases"},{"id":"D051270","term":"Headache Disorders, Primary"},{"id":"D002561","term":"Cerebrovascular Disorders"},{"id":"D051271","term":"Headache Disorders, Secondary"},{"id":"D014652","term":"Vascular Diseases"},{"id":"D002318","term":"Cardiovascular Diseases"},{"id":"D004828","term":"Epilepsies, Partial"},{"id":"D004827","term":"Epilepsy"},{"id":"D000073376","term":"Epileptic Syndromes"}]},"interventionBrowseModule":{"meshes":[{"id":"D000639","term":"Amitriptyline"}],"ancestors":[{"id":"D003986","term":"Dibenzocycloheptenes"},{"id":"D001567","term":"Benzocycloheptenes"},{"id":"D011084","term":"Polycyclic Aromatic Hydrocarbons"},{"id":"D006841","term":"Hydrocarbons, Aromatic"},{"id":"D006844","term":"Hydrocarbons, Cyclic"},{"id":"D006838","term":"Hydrocarbons"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D011083","term":"Polycyclic Compounds"}]}},"hasResults":true}