{"protocolSection":{"identificationModule":{"nctId":"NCT04226365","orgStudyIdInfo":{"id":"2019-83"},"organization":{"fullName":"Lancaster General Hospital","class":"OTHER"},"briefTitle":"Pediatric Concussion Outcomes","officialTitle":"Treatment for Post-concussive Headache: A Randomized, Placebo-controlled, Double Blinded Trial","acronym":"PeCon"},"statusModule":{"statusVerifiedDate":"2025-09","overallStatus":"TERMINATED","whyStopped":"The study was stopped prematurely due to a low enrollment rate.","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2020-02-15","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2023-05-31","type":"ACTUAL"},"completionDateStruct":{"date":"2023-05-31","type":"ACTUAL"},"studyFirstSubmitDate":"2020-01-09","studyFirstSubmitQcDate":"2020-01-09","studyFirstPostDateStruct":{"date":"2020-01-13","type":"ACTUAL"},"resultsFirstSubmitDate":"2024-11-12","resultsFirstSubmitQcDate":"2025-09-09","resultsFirstPostDateStruct":{"date":"2025-09-10","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-09-09","lastUpdatePostDateStruct":{"date":"2025-09-10","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Lancaster General Hospital","class":"OTHER"}},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":false},"descriptionModule":{"briefSummary":"This is a randomized, placebo-controlled, double-blinded trial in which subjects with a post concussive headache meeting inclusion criterion will be assigned to one of two treatment groups: placebo or nortriptyline. Each group will be evaluated at week 0 and again each week for the next 4 weeks of treatment with a concussion survey that rates their symptoms. At the end of 4 weeks the study will be unblinded. It is hypothesized that the addition of nortriptyline to the standard headache treatments will result in more rapid decrease of symptom score than with placebo.","detailedDescription":"Participants are randomly assigned to one of two treatment groups. The experimental group receives standard headache treatment including Tylenol, NSAIDs 2-3x/week, vestibular PT and daily nortriptyline 10mg oral. The control group also receives the standard headache treatment, but will instead be given a placebo, which will look physically identical to the nortriptyline capsule and be comprised of non-active pharmaceutical grade excipient."},"conditionsModule":{"conditions":["Concussion Post Syndrome","Headaches Posttraumatic","Mild Traumatic Brain Injury"],"keywords":["concussion","headache","mild TBI","post concussion"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR"]}},"enrollmentInfo":{"count":8,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Experimental","type":"EXPERIMENTAL","description":"10mg capsule once daily for 4 weeks of nortriptyline","interventionNames":["Drug: Nortriptyline"]},{"label":"Control","type":"PLACEBO_COMPARATOR","description":"10mg capsule once daily for 4 weeks of Thick-It filler","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Nortriptyline","description":"10mg capsule Nortryptyline","armGroupLabels":["Experimental"],"otherNames":["Pamelor"]},{"type":"DRUG","name":"Placebo","description":"10mg capsule Thick-It filler","armGroupLabels":["Control"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Post-Concussive Symptom Inventory (PSCI) Score","description":"Post-Concussive Symptom Inventory (PSCI) score of 0-1 on the headache symptom, where the score ranges from 0 (absent) to 6 (severe). A score of 0 is optimal, while a score of 6 is not optimal.","timeFrame":"4 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Participants aged 13-21 years old\n4. In good general health as evidenced by medical history and diagnosed with recent head trauma meeting ICHD-3 criteria for acute posttraumatic headache with symptom onset \\< 7 days from trauma\n5. Ability to take oral medication and be willing to adhere to the medication regimen\n6. No loss of consciousness OR loss of consciousness \\<30 minutes\n7. Headache symptoms persisting ≥4 weeks post trauma\n8. PCSHE score for headache + pressure in head + neck pain must be \\> 3\n9. After week 4 post-concussion at time of enrollment\n10. Not currently receiving pharmacologic treatment for concussion asid from NSAIDs and acetaminophen\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Focal neurological deficits following injury\n2. Any acute abnormality on Computed Tomography (if obtained)\n3. History of known seizure disorder or moderate or severe TBI\n4. Current uncontrolled psychiatric illness given the potential side effects of the study drug (at investigator discretion).\n5. Current suicidal ideation as screened for on PHQ on intake\n6. A personal history of Brugada syndrome\n7. Known allergic reaction to nortriptyline\n8. Current pregnancy\n9. Positive COVID-19 test in prior 14 days","healthyVolunteers":true,"sex":"ALL","minimumAge":"13 Years","maximumAge":"21 Years","stdAges":["CHILD","ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Patrick Moreno, MD","affiliation":"Lancaster General Health Sports Medicine","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Laura DiPaolo, MD","affiliation":"Lancaster General Health Sports Medicine","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Penn Medicine Lancaster General Health","city":"Lancaster","state":"Pennsylvania","zip":"17602","country":"United States","geoPoint":{"lat":40.03788,"lon":-76.30551}}]},"referencesModule":{"references":[{"pmid":"25670632","type":"BACKGROUND","citation":"Choe MC, Blume HK. Pediatric Posttraumatic Headache: A Review. J Child Neurol. 2016 Jan;31(1):76-85. doi: 10.1177/0883073814568152. Epub 2015 Feb 10."},{"pmid":"27017019","type":"BACKGROUND","citation":"Kacperski J, Hung R, Blume HK. Pediatric Posttraumatic Headache. Semin Pediatr Neurol. 2016 Feb;23(1):27-34. doi: 10.1016/j.spen.2015.08.005. Epub 2015 Aug 19."},{"pmid":"28446457","type":"BACKGROUND","citation":"McCrory P, Meeuwisse W, Dvorak J, Aubry M, Bailes J, Broglio S, Cantu RC, Cassidy D, Echemendia RJ, Castellani RJ, Davis GA, Ellenbogen R, Emery C, Engebretsen L, Feddermann-Demont N, Giza CC, Guskiewicz KM, Herring S, Iverson GL, Johnston KM, Kissick J, Kutcher J, Leddy JJ, Maddocks D, Makdissi M, Manley GT, McCrea M, Meehan WP, Nagahiro S, Patricios J, Putukian M, Schneider KJ, Sills A, Tator CH, Turner M, Vos PE. Consensus statement on concussion in sport-the 5th international conference on concussion in sport held in Berlin, October 2016. Br J Sports Med. 2017 Jun;51(11):838-847. doi: 10.1136/bjsports-2017-097699. Epub 2017 Apr 26. No abstract available."},{"pmid":"28483928","type":"BACKGROUND","citation":"Makdissi M, Schneider KJ, Feddermann-Demont N, Guskiewicz KM, Hinds S, Leddy JJ, McCrea M, Turner M, Johnston KM. Approach to investigation and treatment of persistent symptoms following sport-related concussion: a systematic review. Br J Sports Med. 2017 Jun;51(12):958-968. doi: 10.1136/bjsports-2016-097470. Epub 2017 May 8."},{"pmid":"28422893","type":"BACKGROUND","citation":"Bernard CO, Ponsford JL, McKinlay A, McKenzie D, Krieser D. Do Concussive Symptoms Really Resolve in Young Children? J Head Trauma Rehabil. 2017 Nov/Dec;32(6):413-424. doi: 10.1097/HTR.0000000000000298."},{"pmid":"23560811","type":"BACKGROUND","citation":"Kuczynski A, Crawford S, Bodell L, Dewey D, Barlow KM. Characteristics of post-traumatic headaches in children following mild traumatic brain injury and their response to treatment: a prospective cohort. Dev Med Child Neurol. 2013 Jul;55(7):636-41. doi: 10.1111/dmcn.12152. Epub 2013 Apr 5."},{"pmid":"11869927","type":"BACKGROUND","citation":"Johnson JG, Harris ES, Spitzer RL, Williams JB. The patient health questionnaire for adolescents: validation of an instrument for the assessment of mental disorders among adolescent primary care patients. J Adolesc Health. 2002 Mar;30(3):196-204. doi: 10.1016/s1054-139x(01)00333-0."}],"seeAlsoLinks":[{"label":"Sport concussion assessment tool - 5th edition","url":"https://doi.org/10.1136/bjsports-2017-097506SCAT5"},{"label":"Pamelor \\[package insert\\]. Hazelwood, MO: Mallinckrodt Inc; 2019.","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e17dc299-f52d-414d-ab6e-e809bd6f8acb"}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Experimental","description":"10mg capsule once daily for 4 weeks of nortriptyline\n\nNortriptyline: 10mg capsule Nortryptyline"},{"id":"FG001","title":"Control","description":"10mg capsule once daily for 4 weeks of Thick-It filler\n\nPlacebo: 10mg capsule Thick-It filler"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"4"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"4"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Experimental","description":"10mg capsule once daily for 4 weeks of nortriptyline\n\nNortriptyline: 10mg capsule Nortryptyline"},{"id":"BG001","title":"Control","description":"10mg capsule once daily for 4 weeks of Thick-It filler\n\nPlacebo: 10mg capsule Thick-It filler"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"8"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"8"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"14.5","spread":"2"},{"groupId":"BG001","value":"14.7","spread":"1"},{"groupId":"BG002","value":"14.6","spread":"2"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"4"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"4"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"7"}]},{"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":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"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":"4"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"7"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]},{"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":"4"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"8"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Post-Concussive Symptom Inventory (PSCI) Score","description":"Post-Concussive Symptom Inventory (PSCI) score of 0-1 on the headache symptom, where the score ranges from 0 (absent) to 6 (severe). A score of 0 is optimal, while a score of 6 is not optimal.","populationDescription":"The trial was terminated before the outcome measure data were collected.","reportingStatus":"POSTED","timeFrame":"4 weeks","groups":[{"id":"OG000","title":"Experimental","description":"10mg capsule once daily for 4 weeks of nortriptyline\n\nNortriptyline: 10mg capsule Nortryptyline"},{"id":"OG001","title":"Control","description":"10mg capsule once daily for 4 weeks of Thick-It filler\n\nPlacebo: 10mg capsule Thick-It filler"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"39 months","eventGroups":[{"id":"EG000","title":"Experimental","description":"10mg capsule once daily for 4 weeks of nortriptyline\n\nNortriptyline: 10mg capsule Nortryptyline","deathsNumAffected":0,"deathsNumAtRisk":4,"seriousNumAffected":0,"seriousNumAtRisk":4,"otherNumAffected":2,"otherNumAtRisk":4},{"id":"EG001","title":"Control","description":"10mg capsule once daily for 4 weeks of Thick-It filler\n\nPlacebo: 10mg capsule Thick-It filler","deathsNumAffected":0,"deathsNumAtRisk":4,"seriousNumAffected":0,"seriousNumAtRisk":4,"otherNumAffected":1,"otherNumAtRisk":4}],"otherEvents":[{"term":"Headache/Migraine","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":1,"numAtRisk":4},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":4}]},{"term":"Sever's Apophysitis","organSystem":"Musculoskeletal and connective tissue disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":4},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":4}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true,"restrictiveAgreement":false},"pointOfContact":{"title":"Halle Becker, MPH, Research Project Manager","organization":"Penn Medicine / Lancaster General Hospital","email":"Halle.Becker@pennmedicine.upenn.edu","phone":"7175441777"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot_SAP","hasProtocol":true,"hasSap":true,"hasIcf":false,"label":"Study Protocol and Statistical Analysis Plan","date":"2023-03-31","uploadDate":"2025-01-27T11:05","filename":"Prot_SAP_002.pdf","size":766024},{"typeAbbrev":"ICF","hasProtocol":false,"hasSap":false,"hasIcf":true,"label":"Informed Consent Form: English Version","date":"2023-11-14","uploadDate":"2025-01-27T11:04","filename":"ICF_003.pdf","size":959645}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13","submissionTracking":{"firstMcpInfo":{"postDateStruct":{"date":"2024-12-06","type":"ACTUAL"}}}},"conditionBrowseModule":{"meshes":[{"id":"D038223","term":"Post-Concussion Syndrome"},{"id":"D051298","term":"Post-Traumatic Headache"},{"id":"D001924","term":"Brain Concussion"},{"id":"D006261","term":"Headache"}],"ancestors":[{"id":"D016489","term":"Head Injuries, Closed"},{"id":"D006259","term":"Craniocerebral Trauma"},{"id":"D020196","term":"Trauma, Nervous System"},{"id":"D009422","term":"Nervous System Diseases"},{"id":"D014947","term":"Wounds and Injuries"},{"id":"D014949","term":"Wounds, Nonpenetrating"},{"id":"D051271","term":"Headache Disorders, Secondary"},{"id":"D020773","term":"Headache Disorders"},{"id":"D001927","term":"Brain Diseases"},{"id":"D002493","term":"Central Nervous System Diseases"},{"id":"D000070642","term":"Brain Injuries, Traumatic"},{"id":"D001930","term":"Brain Injuries"},{"id":"D010146","term":"Pain"},{"id":"D009461","term":"Neurologic Manifestations"},{"id":"D012816","term":"Signs and Symptoms"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"}]},"interventionBrowseModule":{"meshes":[{"id":"D009661","term":"Nortriptyline"}],"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}