[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07634146":3,"trial-entities:NCT07634146":133,"trial-summary:NCT07634146":136},{"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":15,"conditions":17,"keywords":26,"study_type":36,"primary_purpose":14,"phases":37,"enrollment_info":39,"interventions":42,"primary_outcomes":64,"secondary_outcomes":69,"sex":91,"minimum_age":92,"maximum_age":93,"healthy_volunteers":94,"eligibility_criteria":95,"std_ages":109,"locations":112,"central_contacts":128,"overall_officials":130,"references":131,"see_also_links":132},"NCT07634146","2026-0040","Evaluation of the Migraceutics® Phase-Specific Dietary Supplement Regimen on Quality of Life, Work Productivity, and Biomarkers in Adult Migraineurs: The Migraceutics® START Study","A Randomized, Sham Supplement- and Care-as-Usual-Controlled Study to Evaluate Migraceutics® Phase-Specific Dietary Supplement Regimen on Quality of Life, Work Productivity, and Biomarkers in Adult Migraineurs: The Migraceutics® START Study","NOT_YET_RECRUITING","2028-06-30","2026-05","2026-06-08","2026-07-08","Miracle Wellness LLC","OTHER",null,"The purpose of this study is to evaluate the impact of the Migraceutics® phase-specific dietary supplement regimen on quality of life, work productivity, and biomarkers in adult migraineurs.",[18,19,20,21,22,23,24,25],"Migraine","Migraine Disease","Migraine Disorder","Migraine Headache","Migraine Disability","Migraine in Adults","Menstrual Migraine","Menstrual Migraine (MM) Headaches",[27,28,29,30,31,32,33,34,35],"quality of life","productivity","disability","CGRP","headache","migraine","nutraceuticals","dietary supplement","migraceuticals","INTERVENTIONAL",[38],"NA",{"count":40,"type":41},920,"ESTIMATED",[43,51,55,59],{"type":44,"name":45,"description":46,"armGroupLabels":47},"DIETARY_SUPPLEMENT","Foundational dietary supplement","Foundational dietary supplement, self-administered daily.",[48,49,50],"Arm 3 - Care as usual (CAU) + Foundational dietary supplement","Arm 4a - Care as usual (CAU) + Foundational dietary supplement + Migraine phase add-on supplement","Arm 4b - Care as usual (CAU) + Foundational dietary supplement + Luteal phase add-on supplement",{"type":44,"name":52,"description":53,"armGroupLabels":54},"Luteal phase dietary supplement add-on","Add-on dietary supplement, self-administered to women with menstrual migraine during the luteal phase of their menstruation cycle.",[50],{"type":44,"name":56,"description":57,"armGroupLabels":58},"Migraine phase dietary supplement add-on","Add-on dietary supplement, self-administered during the symptomatic migraine phase.",[49],{"type":44,"name":60,"description":61,"armGroupLabels":62},"Reference dietary supplement","Reference comparator supplement, self-administered daily.",[63],"Arm 2 - Care as usual (CAU) + Reference dietary supplement",[65],{"measure":66,"description":67,"timeFrame":68},"Changes from baseline in migraine-related quality of life","Changes from baseline in migraine-related quality of life as measured by the mean Headache Impact Test (HIT-6) total score. HIT-6 has six questions, which are rated using a five-level scale: Never (6 points), Rarely (8 points), Sometimes (10 points), Very Often (11 points), and Always (13 points). Total scores can range from 36 to 78, with higher totals reflecting a more significant impact.","Baseline, Month 1 through Month 6",[70,73,76,79,82,85,88],{"measure":71,"description":72,"timeFrame":68},"Number of self-reported migraine days per month","The number of calendar days within a 28-day (or pre-specified) period on which a participant experiences any migraine.",{"measure":74,"description":75,"timeFrame":68},"Distribution of participants experiencing changes in monthly migraine days","Distribution of participants in various levels of change (e.g., ≥25%, ≥50%, ≥75%, 100% change) from baseline.",{"measure":77,"description":78,"timeFrame":68},"Use of over-the-counter or prescription migraine or headache medication","Mean number of migraine days associated with use of over-the-counter or prescription migraine or headache medication",{"measure":80,"description":81,"timeFrame":68},"Migraine symptoms participants experienced","Mean monthly number of migraine symptoms.",{"measure":83,"description":84,"timeFrame":68},"Self-reported migraine symptom severity","Self-reported migraine symptom severity scores. Participants rate each of their reported symptoms on a scale from 0 to 10 how bad these symptoms were at their worst. 0: I did not have this symptom, and 10: it was the worst imaginable",{"measure":86,"description":87,"timeFrame":68},"Mean number of migraine hours","Mean number of hours in the past 30 days on which a migraine occurred",{"measure":89,"description":90,"timeFrame":68},"Number of missed work and\u002For school days due to migraine","Number of missed work and\u002For school days per month (self-reported)","ALL","18 Years","65 Years",false,{"inclusion":96,"exclusion":101,"raw_text":108},[97,98,99,100],"Self-reported history of migraine, based on the International Headache Society (IHS) International Classification of Headache Disorders, 3rd edition (ICHD-3) diagnostic criteria for migraine.","Being able to take oral supplements.","Agreeing to maintain their regular lifestyle.","Access to internet and telephone.",[102,103,104,105,106,107],"Pregnancy or lactation.","Presence of any active medical condition or diagnosis other than episodic migraine, including liver or kidney disease or condition.","Use of overlapping supplements or interacting medications.","Known allergies to study ingredients.","Daily use of alcohol, tobacco, or recreational drugs.","Participation in any other clinical or interventional study within 30 days prior to baseline or concurrently.","Inclusion Criteria:\n\n* Self-reported history of migraine, based on the International Headache Society (IHS) International Classification of Headache Disorders, 3rd edition (ICHD-3) diagnostic criteria for migraine.\n* Being able to take oral supplements.\n* Agreeing to maintain their regular lifestyle.\n* Access to internet and telephone.\n\nExclusion Criteria:\n\n* Pregnancy or lactation.\n* Presence of any active medical condition or diagnosis other than episodic migraine, including liver or kidney disease or condition.\n* Use of overlapping supplements or interacting medications.\n* Known allergies to study ingredients.\n* Daily use of alcohol, tobacco, or recreational drugs.\n* Participation in any other clinical or interventional study within 30 days prior to baseline or concurrently.",[110,111],"ADULT","OLDER_ADULT",[113],{"facility":114,"city":115,"state":116,"zip":117,"country":118,"contacts":119,"geoPoint":125},"Natural Migraceuticals","Lutherville-Timonium","Maryland","21093","United States",[120],{"name":121,"role":122,"phone":123,"email":124},"Principal Investigator","CONTACT","443-220-3558","info@migraceutics.com",{"lat":126,"lon":127},39.43997,-76.61099,[129],{"name":121,"role":122,"phone":123,"email":124},[],[],[],{"nct_id":4,"conditions":134,"biomarkers":135},[18],[],{"nct_id":4,"found":94,"summary":15,"prompt_version":15}]