[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07310290":3,"trial-entities:NCT07310290":89,"trial-summary:NCT07310290":92},{"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":17,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":29,"secondary_outcomes":34,"sex":35,"minimum_age":36,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":37,"std_ages":48,"locations":51,"central_contacts":77,"overall_officials":83,"references":87,"see_also_links":88},"NCT07310290","P25-590","Study to Assess the Real-World Effectiveness of Ubrogepant in Adult Participants When Treating During the Prodrome Phase of Migraine Attacks","PHASES: Prodrome in tHe reAl World: aSsESsing Ubrogepant Acute Use","RECRUITING","2027-03","2026-02","2026-02-10","2026-01-27","AbbVie","INDUSTRY",false,"Migraine is a neurological disease characterized by moderate or severe headaches, associated with nausea, vomiting, and\u002For sensitivity to light and sound. This study will assess changes in migraine attack severity for adult participants treating with oral ubrogepant across migraine attacks.\n\nUbrogepant is a drug that is approved for the acute treatment of migraine in adults. Approximately 189 participants will be enrolled in approximately 15 sites across the US.\n\nParticipants will receive ubrogepant as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 13 weeks.\n\nThere is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.",null,[19],"Migraine",[19,21,22],"Ubrogepant","UBRELVY","OBSERVATIONAL",[],{"count":26,"type":27},189,"ESTIMATED",[],[30],{"measure":31,"description":32,"timeFrame":33},"Percentage of Participants with Absence of moderate to severe headache over 24 hours post-dose during prodrome.","Prodrome is often the earliest phase of migraine attack and consists of various symptoms including sensitivity to light, fatigue, neck pain, sensitivity to sound, dizziness and difficulty thinking\u002Fconcentrating.","Up to approximately 13 weeks",[],"ALL","18 Years",{"inclusion":38,"exclusion":43,"raw_text":47},[39,40,41,42],"History of 4 to 10 migraine days per month with moderate to severe headache pain in each month of the 3 months prior to Visit 1","a. Participants with a diagnosis of chronic migraine who report having 4 to 10 migraine days per month with moderate to severe headache pain in each month of the 3 months prior to Visit 1 due to concomitant preventive treatment are allowed in the study","Participant is currently prescribed ubrogepant and has been using ubrogepant for at least 3 months for the acute treatment of migraine in adults, according to the US Food and Drug Administration (FDA)-approved indication","Adult participants with current clinical diagnosis of migraine or chronic migraine according to International Classification of Headache Disorders (ICHD)-3",[44,45,46],"Currently participating in a concurrent clinical or non-interventional study.","Concomitant use with a strong Cytochrome P450 3A4 (CYP3A4 ) inhibitor.","Current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia, status migrainosus or painful cranial neuropathy as defined by ICHD-3","Inclusion Criteria:\n\n* History of 4 to 10 migraine days per month with moderate to severe headache pain in each month of the 3 months prior to Visit 1\n\n  --a. Participants with a diagnosis of chronic migraine who report having 4 to 10 migraine days per month with moderate to severe headache pain in each month of the 3 months prior to Visit 1 due to concomitant preventive treatment are allowed in the study\n* Participant is currently prescribed ubrogepant and has been using ubrogepant for at least 3 months for the acute treatment of migraine in adults, according to the US Food and Drug Administration (FDA)-approved indication\n* Adult participants with current clinical diagnosis of migraine or chronic migraine according to International Classification of Headache Disorders (ICHD)-3\n\nExclusion Criteria:\n\n* Currently participating in a concurrent clinical or non-interventional study.\n* Concomitant use with a strong Cytochrome P450 3A4 (CYP3A4 ) inhibitor.\n* Current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia, status migrainosus or painful cranial neuropathy as defined by ICHD-3",[49,50],"ADULT","OLDER_ADULT",[52,61,69],{"facility":53,"status":8,"city":54,"state":55,"zip":56,"country":57,"geoPoint":58},"Neurology and Pain Specialty Center \u002FID# 278508","Aliso Viejo","California","92656","United States",{"lat":59,"lon":60},33.56504,-117.72712,{"facility":62,"status":8,"city":63,"state":64,"zip":65,"country":57,"geoPoint":66},"Chicago Headache Center & Research Inst \u002FID# 272345","Naperville","Illinois","60563",{"lat":67,"lon":68},41.78586,-88.14729,{"facility":70,"status":8,"city":71,"state":72,"zip":73,"country":57,"geoPoint":74},"Tri City Research Center, LLC \u002FID# 278800","Grand Island","Nebraska","68803",{"lat":75,"lon":76},40.92501,-98.34201,[78],{"name":79,"role":80,"phone":81,"email":82},"Krystal Spenta","CONTACT","844-663-3742","krystal.spenta@abbvie.com",[84],{"name":85,"affiliation":13,"role":86},"ABBVIE INC.","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":90,"biomarkers":91},[19],[],{"nct_id":4,"found":93,"summary":94,"prompt_version":17},true,{"design":95,"status":96,"heading":97,"summary":98,"follow_up":99,"word_count":100,"commitments":101,"compensation":102,"drugs_mentioned":103},"This is an observational study involving approximately 189 adult participants. It is not specified if it is blinded or randomized.","completed","Ubrogepant for Migraine Treatment During Prodrome","This study is looking at how well ubrogepant works for adults who treat their migraine attacks during the prodrome phase (the time before a migraine headache starts). Ubrogepant is an approved medication for acute migraine treatment. Researchers want to see if taking ubrogepant at this early stage helps prevent moderate to severe headaches for 24 hours after treatment. You might be able to join if you are an adult with 4 to 10 migraine days per month, with moderate to severe headache pain, for the past three months. This is an observational study, meaning you would take ubrogepant as prescribed by your doctor. About 189 people will participate across the US. The study's current status is unclear.","Participants will be followed for up to approximately 13 weeks.",117,"You would take ubrogepant as prescribed by your physician according to your routine clinical practice. There is expected to be no additional burden for participants.","Not stated in the trial record.",[]]