[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05127954":3,"trial-entities:NCT05127954":875,"trial-summary:NCT05127954":878},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":38,"secondary_outcomes":65,"sex":66,"minimum_age":67,"maximum_age":68,"healthy_volunteers":69,"eligibility_criteria":70,"std_ages":81,"locations":83,"central_contacts":865,"overall_officials":866,"references":870,"see_also_links":871},"NCT05127954","3110-306-002","Long-term Extension Study to Assess Safety and Tolerability of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Pediatric Participants (Ages 6-17)","A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine With or Without Aura in Children and Adolescents (Ages 6-17)","ENROLLING_BY_INVITATION","2028-01","2025-07","2025-07-20","2022-01-14","AbbVie","INDUSTRY",true,"Migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound. Migraine is extremely common and disabling in children. The purpose of this study is to evaluate long term safety and tolerability of ubrogepant in the acute treatment of migraine in pediatric participants.\n\nUbrogepant is a drug approved for the acute treatment of migraine in adults. Pediatric participants (aged 6-17 years) with a history of migraine will be enrolled. Participants who completed the lead-in Study 3110-305-002, as well as those who were placebo responders and screen failed, will be eligible to enroll into this study. Around 1200 participants will be enrolled in the study at approximately 120 sites in the United States.\n\nParticipants may receive ubrogepant oral tables to treat up to 8 migraine attacks of any intensity per month. There will be an option to take a second dose of study intervention (identical to initial dose), or rescue medication, starting 2 hours after the initial dose. The study duration will be up to 54 weeks.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.",null,[19],"Migraine",[19,21,22],"Ubrogepant","Ubrelvy","INTERVENTIONAL","TREATMENT",[26],"PHASE3",{"count":28,"type":29},1200,"ESTIMATED",[31],{"type":32,"name":21,"description":33,"armGroupLabels":34,"otherNames":37},"DRUG","Oral Tablet",[35,36],"Ubrogepant Dose A (12 to 17 Years Old)","Ubrogepant Dose B (6 to 11 Years Old)",[22],[39,43,47,50,53,56,59,62],{"measure":40,"description":41,"timeFrame":42},"Percentage of Participants with Adverse Events (AEs)","An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.","up to 54 weeks",{"measure":44,"description":45,"timeFrame":46},"Percentage of Participants with Potentially Clinically Significant Clinical 12-lead Electrocardiogram (ECG)","12-lead resting ECGs will be recorded. Parameters include heart rate, PR interval, QT interval, QRS duration, and QT interval corrected using Fridericia's formula (QTcF).","Up to 54 Weeks",{"measure":48,"description":49,"timeFrame":46},"Percentage of Participants with Potentially Clinically Significant Vital Sign Parameters","Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.",{"measure":51,"description":52,"timeFrame":46},"Percentage of Participants with Potentially Clinically Significant lab values","Percentage of participants with abnormal change in clinical laboratory test results like hematology will be assessed.",{"measure":54,"description":55,"timeFrame":46},"Percentage of with Participants with Suicidal Ideation or Suicidal Behavior","The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation was classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods \\[not plan\\] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt).",{"measure":57,"description":58,"timeFrame":46},"Percentage of Participants with Change in Menstrual Cycle","Female participants who have entered menarche are to be asked for the date of the first and last day of their most recent menstrual period.",{"measure":60,"description":61,"timeFrame":46},"Change from baseline in Tanner staging score","Tanner's staging is used to assess growth and pubertal development.",{"measure":63,"description":64,"timeFrame":42},"Change From baseline in Behavior Rating Inventory of Executive Function (BRIEF 2) questionnaire","The BRIEF 2 is an 86-item questionnaire assessing executive function. It consists of 2 indexes, Behavioral Regulation and Metacognition, which are then used to calculate an overall composite score. Higher scores indicate more executive difficulties",[],"ALL","6 Years","17 Years",false,{"inclusion":71,"exclusion":74,"raw_text":80},[72,73],"Completers of the lead-in Study 3110-305-002 (in the main study or PK cohort) or those who screen failed due to being placebo responders.","Demonstrated an acceptable degree of compliance with study procedures in the lead-in study and who, in the investigator's clinical judgment, did not experience an AE that may indicate an unacceptable safety risk for this study.",[75,76,77,78,79],"Requirement for any medication (eg, barbiturates) or diet (eg, grapefruit juice) that is on the list of prohibited concomitant medications that cannot be discontinued or switched to an allowable, alternative medication at Visit 1.","An ECG with clinically significant abnormalities at Visit 1 as determined by the investigator.","Clinically significant abnormalities in physical examination at Visit 1, as determined by the investigator.","Significant risk of self-harm, based on clinical interview and responses on the C-SSRS, or of harm to others in the opinion of the investigator; participants should be excluded if they report suicidal ideation with intent, with or without a plan (ie, Type 4 or 5 on the C-SSRS), or report suicidal behavior at Visit 1","Any medical or other reason (eg, unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study) that, in the investigator's opinion, might indicate that the participant is unsuitable for the study.","Inclusion Criteria:\n\n* Completers of the lead-in Study 3110-305-002 (in the main study or PK cohort) or those who screen failed due to being placebo responders.\n* Demonstrated an acceptable degree of compliance with study procedures in the lead-in study and who, in the investigator's clinical judgment, did not experience an AE that may indicate an unacceptable safety risk for this study.\n\nExclusion Criteria:\n\n* Requirement for any medication (eg, barbiturates) or diet (eg, grapefruit juice) that is on the list of prohibited concomitant medications that cannot be discontinued or switched to an allowable, alternative medication at Visit 1.\n* An ECG with clinically significant abnormalities at Visit 1 as determined by the investigator.\n* Clinically significant abnormalities in physical examination at Visit 1, as determined by the investigator.\n* Significant risk of self-harm, based on clinical interview and responses on the C-SSRS, or of harm to others in the opinion of the investigator; participants should be excluded if they report suicidal ideation with intent, with or without a plan (ie, Type 4 or 5 on the C-SSRS), or report suicidal behavior at Visit 1\n* Any medical or other reason (eg, unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study) that, in the investigator's opinion, might indicate that the participant is unsuitable for the study.",[82],"CHILD",[84,93,100,108,116,123,130,137,144,151,158,165,172,180,187,194,202,210,218,225,232,239,246,253,260,267,274,278,282,289,296,303,310,317,324,331,339,343,347,354,361,368,375,383,391,399,407,411,415,422,430,438,446,454,461,469,477,485,493,500,507,515,522,528,535,542,550,557,565,569,573,577,584,591,599,607,615,622,629,637,644,651,659,667,671,674,681,688,692,699,706,713,717,724,731,738,745,752,759,766,774,781,785,793,801,808,815,823,831,839,847,854,861],{"facility":85,"city":86,"state":87,"zip":88,"country":89,"geoPoint":90},"Rehabilitation & Neurological Services \u002FID# 240054","Huntsville","Alabama","35805-4046","United States",{"lat":91,"lon":92},34.7304,-86.58594,{"facility":94,"city":95,"state":87,"zip":96,"country":89,"geoPoint":97},"The Center for Clinical Trials - Saraland \u002FID# 239448","Saraland","36571",{"lat":98,"lon":99},30.82074,-88.07056,{"facility":101,"city":102,"state":103,"zip":104,"country":89,"geoPoint":105},"Preferred Research Partners \u002FID# 238979","Little Rock","Arkansas","72211",{"lat":106,"lon":107},34.74648,-92.28959,{"facility":109,"city":110,"state":111,"zip":112,"country":89,"geoPoint":113},"Advanced Research Center \u002FID# 238967","Anaheim","California","92805",{"lat":114,"lon":115},33.83529,-117.9145,{"facility":117,"city":118,"state":111,"zip":119,"country":89,"geoPoint":120},"Neuro Pain Medical Center \u002FID# 239135","Fresno","93710",{"lat":121,"lon":122},36.74773,-119.77237,{"facility":124,"city":125,"state":111,"zip":126,"country":89,"geoPoint":127},"Alliance for Research Alliance for Wellness \u002FID# 233497","Long Beach","90807",{"lat":128,"lon":129},33.76696,-118.18923,{"facility":131,"city":132,"state":111,"zip":133,"country":89,"geoPoint":134},"Children's Hospital Los Angeles \u002FID# 239446","Los Angeles","90027",{"lat":135,"lon":136},34.05223,-118.24368,{"facility":138,"city":139,"state":111,"zip":140,"country":89,"geoPoint":141},"Excell Research, Inc \u002FID# 233495","Oceanside","92056",{"lat":142,"lon":143},33.19587,-117.37948,{"facility":145,"city":146,"state":111,"zip":147,"country":89,"geoPoint":148},"Paradigm Clinical Research - San Diego \u002FID# 269611","San Diego","92108-1681",{"lat":149,"lon":150},32.71571,-117.16472,{"facility":152,"city":153,"state":111,"zip":154,"country":89,"geoPoint":155},"Lumos Clinical Research Center \u002FID# 239018","San Jose","95124-4108",{"lat":156,"lon":157},37.33939,-121.89496,{"facility":159,"city":160,"state":111,"zip":161,"country":89,"geoPoint":162},"Pacific Clinical Research Management Group \u002FID# 238503","Upland","91786",{"lat":163,"lon":164},34.09751,-117.64839,{"facility":166,"city":167,"state":111,"zip":168,"country":89,"geoPoint":169},"Sunwise Clinical Research \u002FID# 238458","Walnut Creek","94596",{"lat":170,"lon":171},37.90631,-122.06496,{"facility":173,"city":174,"state":175,"zip":176,"country":89,"geoPoint":177},"Children's Hospital Colorado - Aurora \u002FID# 239838","Aurora","Colorado","80045",{"lat":178,"lon":179},39.72943,-104.83192,{"facility":181,"city":182,"state":175,"zip":183,"country":89,"geoPoint":184},"IMMUNOe Research Centers \u002FID# 240846","Centennial","80112",{"lat":185,"lon":186},39.57916,-104.87692,{"facility":188,"city":189,"state":175,"zip":190,"country":89,"geoPoint":191},"MCB Clinical Research Centers \u002FID# 240999","Colorado Springs","80910",{"lat":192,"lon":193},38.83388,-104.82136,{"facility":195,"city":196,"state":197,"zip":198,"country":89,"geoPoint":199},"New England Institute for Clinical Research \u002FID# 239019","Stamford","Connecticut","06905",{"lat":200,"lon":201},41.05343,-73.53873,{"facility":203,"city":204,"state":205,"zip":206,"country":89,"geoPoint":207},"Emerson Clinical Research Inst \u002FID# 238455","Washington D.C.","District of Columbia","20011",{"lat":208,"lon":209},38.89511,-77.03637,{"facility":211,"city":212,"state":213,"zip":214,"country":89,"geoPoint":215},"Encore Medical Research of Boynton Beach LLC \u002FID# 248720","Boynton Beach","Florida","33436-7245",{"lat":216,"lon":217},26.52535,-80.06643,{"facility":219,"city":220,"state":213,"zip":221,"country":89,"geoPoint":222},"Gulf Coast Clinical Research Center \u002FID# 233335","Fort Myers","33912",{"lat":223,"lon":224},26.62168,-81.84059,{"facility":226,"city":227,"state":213,"zip":228,"country":89,"geoPoint":229},"Sarkis Clinical Trials \u002FID# 233493","Gainesville","32607",{"lat":230,"lon":231},29.65163,-82.32483,{"facility":233,"city":234,"state":213,"zip":235,"country":89,"geoPoint":236},"Northwest Florida Clinical Research Group, LLC \u002FID# 244396","Gulf Breeze","32561-4495",{"lat":237,"lon":238},30.35714,-87.16386,{"facility":240,"city":241,"state":213,"zip":242,"country":89,"geoPoint":243},"A.G.A Clinical Trials \u002FID# 238409","Hialeah","33012",{"lat":244,"lon":245},25.8576,-80.27811,{"facility":247,"city":248,"state":213,"zip":249,"country":89,"geoPoint":250},"Encore Medical Research \u002FID# 247463","Hollywood","33021",{"lat":251,"lon":252},26.0112,-80.14949,{"facility":254,"city":255,"state":213,"zip":256,"country":89,"geoPoint":257},"Advanced Research Institute of Miami \u002FID# 240712","Homestead","33030-4613",{"lat":258,"lon":259},25.46872,-80.47756,{"facility":261,"city":262,"state":213,"zip":263,"country":89,"geoPoint":264},"Auzmer Research \u002FID# 241514","Lakeland","33813-2768",{"lat":265,"lon":266},28.03947,-81.9498,{"facility":268,"city":269,"state":213,"zip":270,"country":89,"geoPoint":271},"Columbus Clinical Services, Llc \u002FId# 238968","Miami","33125",{"lat":272,"lon":273},25.77427,-80.19366,{"facility":275,"city":269,"state":213,"zip":276,"country":89,"geoPoint":277},"My Preferred Research LLC \u002FID# 239020","33155",{"lat":272,"lon":273},{"facility":279,"city":269,"state":213,"zip":280,"country":89,"geoPoint":281},"Neurology & Pain Medicine \u002FID# 241860","33186-7661",{"lat":272,"lon":273},{"facility":283,"city":284,"state":213,"zip":285,"country":89,"geoPoint":286},"Medical Research Group of Central Florida \u002FID# 240711","Orange City","32763",{"lat":287,"lon":288},28.94888,-81.29867,{"facility":290,"city":291,"state":213,"zip":292,"country":89,"geoPoint":293},"Clinical Associates of Orlando, LLC \u002FID# 272623","Orlando","32819",{"lat":294,"lon":295},28.53834,-81.37924,{"facility":297,"city":298,"state":213,"zip":299,"country":89,"geoPoint":300},"Suncoast Clinical Research - Palm Harbor \u002FID# 233535","Palm Harbor","34684",{"lat":301,"lon":302},28.07807,-82.76371,{"facility":304,"city":305,"state":213,"zip":306,"country":89,"geoPoint":307},"Asclepes Research Centers - Spring Hill \u002FID# 231872","Spring Hill","34609-5692",{"lat":308,"lon":309},28.47688,-82.52546,{"facility":311,"city":312,"state":213,"zip":313,"country":89,"geoPoint":314},"University of South Florida- Neuroscience Institute \u002FID# 233420","Tampa","33613",{"lat":315,"lon":316},27.94752,-82.45843,{"facility":318,"city":319,"state":213,"zip":320,"country":89,"geoPoint":321},"Encore Medical Research - Weston \u002FID# 248335","Weston","33331",{"lat":322,"lon":323},26.10037,-80.39977,{"facility":325,"city":326,"state":213,"zip":327,"country":89,"geoPoint":328},"Pediatric Neurology and Epilepsy Specialists \u002FID# 233336","Winter Park","32789-7111",{"lat":329,"lon":330},28.6,-81.33924,{"facility":332,"city":333,"state":334,"zip":335,"country":89,"geoPoint":336},"Global Research Associates \u002FID# 243504","Atlanta","Georgia","30315",{"lat":337,"lon":338},33.749,-84.38798,{"facility":340,"city":333,"state":334,"zip":341,"country":89,"geoPoint":342},"Rare Disease Research, LLC \u002FID# 238833","30318-2512",{"lat":337,"lon":338},{"facility":344,"city":333,"state":334,"zip":345,"country":89,"geoPoint":346},"Clinical Integrative Research Center of Atlanta (CIRCA) \u002FID# 238852","30328",{"lat":337,"lon":338},{"facility":348,"city":349,"state":334,"zip":350,"country":89,"geoPoint":351},"Coastal Georgia Child Neurology \u002FID# 240845","Brunswick","31520-1601",{"lat":352,"lon":353},31.15013,-81.49147,{"facility":355,"city":356,"state":334,"zip":357,"country":89,"geoPoint":358},"CenExcel iResearch LLC \u002FID# 239832","Decatur","30030",{"lat":359,"lon":360},33.77483,-84.29631,{"facility":362,"city":363,"state":334,"zip":364,"country":89,"geoPoint":365},"Velocity Clinical Research - Savannah \u002FID# 231873","Savannah","31406",{"lat":366,"lon":367},32.08354,-81.09983,{"facility":369,"city":370,"state":334,"zip":371,"country":89,"geoPoint":372},"Sleep Care Research Institute d\u002Fb\u002Fa Clinical Research Institute \u002FID# 238454","Stockbridge","30281",{"lat":373,"lon":374},33.54428,-84.23381,{"facility":376,"city":377,"state":378,"zip":379,"country":89,"geoPoint":380},"Velocity Clinical Research - Boise \u002FID# 238978","Meridian","Idaho","83642",{"lat":381,"lon":382},43.61211,-116.39151,{"facility":384,"city":385,"state":386,"zip":387,"country":89,"geoPoint":388},"Chicago Headache Center & Research Institute \u002FID# 254071","Chicago","Illinois","60657",{"lat":389,"lon":390},41.85003,-87.65005,{"facility":392,"city":393,"state":394,"zip":395,"country":89,"geoPoint":396},"Accellacare - McFarland Clinic \u002FID# 238490","Ames","Iowa","50010",{"lat":397,"lon":398},42.03471,-93.61994,{"facility":400,"city":401,"state":402,"zip":403,"country":89,"geoPoint":404},"College Park Family Care Center Overland Park \u002FID# 240707","Overland Park","Kansas","66210-2761",{"lat":405,"lon":406},38.98223,-94.67079,{"facility":408,"city":401,"state":402,"zip":409,"country":89,"geoPoint":410},"Clinical Associates Midwest, LLC \u002FID# 274356","66214",{"lat":405,"lon":406},{"facility":412,"city":401,"state":402,"zip":413,"country":89,"geoPoint":414},"Psychiatric Associates \u002FID# 240710","66221",{"lat":405,"lon":406},{"facility":416,"city":417,"state":402,"zip":418,"country":89,"geoPoint":419},"Alliance for Multispecialty Research (AMR) - Wichita West \u002FID# 239829","Wichita","67205-1138",{"lat":420,"lon":421},37.69224,-97.33754,{"facility":423,"city":424,"state":425,"zip":426,"country":89,"geoPoint":427},"University of Kentucky Chandler Medical Center \u002FID# 233428","Lexington","Kentucky","40536",{"lat":428,"lon":429},37.98869,-84.47772,{"facility":431,"city":432,"state":433,"zip":434,"country":89,"geoPoint":435},"Pharmasite Research, Inc. \u002FID# 233414","Baltimore","Maryland","21208",{"lat":436,"lon":437},39.29038,-76.61219,{"facility":439,"city":440,"state":441,"zip":442,"country":89,"geoPoint":443},"Minneapolis Clinic of Neurology - Burnsville \u002FID# 238828","Burnsville","Minnesota","55337-6732",{"lat":444,"lon":445},44.76774,-93.27772,{"facility":447,"city":448,"state":449,"zip":450,"country":89,"geoPoint":451},"MediSync Clinical Research Hattiesburg Clinic \u002FID# 239837","Petal","Mississippi","39465-2932",{"lat":452,"lon":453},31.34656,-89.26006,{"facility":455,"city":456,"state":449,"zip":457,"country":89,"geoPoint":458},"Proven Endpoints LLC \u002FID# 240974","Ridgeland","39157",{"lat":459,"lon":460},32.42848,-90.13231,{"facility":462,"city":463,"state":464,"zip":465,"country":89,"geoPoint":466},"Sharlin Health Neuroscience Research Center \u002FID# 238969","Ozark","Missouri","65721-5315",{"lat":467,"lon":468},37.02089,-93.20602,{"facility":470,"city":471,"state":472,"zip":473,"country":89,"geoPoint":474},"Cognitive Clinical Trials (CCT) - Papillion \u002FID# 239835","Papillion","Nebraska","68046-4131",{"lat":475,"lon":476},41.15444,-96.04224,{"facility":478,"city":479,"state":480,"zip":481,"country":89,"geoPoint":482},"Healthy Perspectives - Innovative Mental Health Services, PLLC \u002FID# 239441","Nashua","New Hampshire","03060-3483",{"lat":483,"lon":484},42.76537,-71.46757,{"facility":486,"city":487,"state":488,"zip":489,"country":89,"geoPoint":490},"Hunterdon Neurology \u002FID# 248222","Annandale","New Jersey","08801-3127",{"lat":491,"lon":492},40.64093,-74.88128,{"facility":494,"city":495,"state":488,"zip":496,"country":89,"geoPoint":497},"Goryeb Children's Hospital \u002FID# 239425","Morristown","07960",{"lat":498,"lon":499},40.79677,-74.48154,{"facility":501,"city":502,"state":488,"zip":503,"country":89,"geoPoint":504},"CVS HealthHUB - Runnemede \u002FID# 240057","Runnemede","08078-1034",{"lat":505,"lon":506},39.85234,-75.06795,{"facility":508,"city":509,"state":510,"zip":511,"country":89,"geoPoint":512},"Dent Neurologic Institute - 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