[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06904287":3,"trial-entities:NCT06904287":111,"trial-summary:NCT06904287":114},{"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":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":40,"secondary_outcomes":45,"sex":61,"minimum_age":62,"maximum_age":63,"healthy_volunteers":15,"eligibility_criteria":64,"std_ages":78,"locations":81,"central_contacts":97,"overall_officials":106,"references":109,"see_also_links":110},"NCT06904287","IRB00127959","Effectiveness of Magnesium in Addition to Prochlorperazine for the Treatment of Migraines","Evaluating the Effectiveness of Magnesium in Addition to Prochlorperazine for the Treatment of Migraines in the Emergency Department","RECRUITING","2027-06","2026-01","2026-01-22","2025-12-16","Wake Forest University Health Sciences","OTHER",false,"The purpose of this research study is to find out if using magnesium in addition to prochlorperazine will help reduce your migraine pain.","The purpose of this prospective, randomized, double-blinded study is to compare the relative efficacy and safety of intravenous magnesium in conjunction with intravenous prochlorperazine in the treatment of migraines. Participants will be patients presenting to the Emergency Department with primary diagnosis of migraine.",[19],"Migraine",[19,21],"Magnesium","INTERVENTIONAL","TREATMENT",[25],"PHASE3",{"count":27,"type":28},100,"ESTIMATED",[30,35],{"type":31,"name":21,"description":32,"armGroupLabels":33},"DRUG","Prochlorperazine 10 mg administered as an intravenous push over 2 minutes followed by magnesium 2 g administered as an intravenous bolus over a period of 20 minutes",[34],"Study Drug",{"type":31,"name":36,"description":37,"armGroupLabels":38},"Placebo","Prochlorperazine 10 mg administered as an intravenous push over 2 minutes followed by placebo (normal saline)",[39],"Control Arm",[41],{"measure":42,"description":43,"timeFrame":44},"Mean change in pain - baseline to 30 minutes","Change in pain score 30 minutes after initiation of infusion. Pain score is measured on a 0-11 point pain intensity numerical rating scale where 0=no pain and 10=worst possible pain.","Baseline to 30 minutes after initiation of infusion",[46,50,54,58],{"measure":47,"description":48,"timeFrame":49},"Mean change in pain - baseline to 45 minutes and baseline to 60 minutes","Change in pain score 45 minutes and 60 minutes after initiation of infusion. Pain score is measured on a 0-11 point pain intensity numerical rating scale where 0=no pain and 10=worst possible pain.","Baseline to 45 minutes and 60 minutes after initiation of infusion",{"measure":51,"description":52,"timeFrame":53},"Number of adverse events","Number of adverse events related to study drug within first 2 hours of study drug infusion. Adverse events include hypotension, flushing, akathisia, dystonia, nausea\u002Fvomiting, dizziness, drowsiness.","Infusion through hour 2",{"measure":55,"description":56,"timeFrame":57},"Emergency Department length of stay","Total time spent in emergency department up until discharge","Hour 24",{"measure":59,"description":60,"timeFrame":53},"Number of patients that require rescue medications","Number of patients that require administration of rescue meds, which include acetaminophen, NSAIDs, or additional antidopaminergic agents, given within first 2 hours after infusion.","ALL","18 Years",null,{"inclusion":65,"exclusion":70,"raw_text":77},[66,67,68,69],"Age ≥ 18 years or older","Able to provide informed consent","English speaking","Primary diagnosis of migraine. Patient with a previous diagnosis of migraine, who experience headaches with typical migraine features (e.g at least 2-3 of the following: recurrent, unilateral, pounding or throbbing in nature, associated with nausea), AND with a clinical exclusion of migraine mimics",[71,72,73,74,75,76],"Pregnancy defined as a positive urine HCG","Allergy or sensitivity to study drug","Stated history of renal insufficiency","Documented history of myasthenia gravis","Consumption of study drug within 48 hours prior to enrollment","Previously enrolled in this trial during a different patient encounter","Inclusion Criteria:\n\n* Age ≥ 18 years or older\n* Able to provide informed consent\n* English speaking\n* Primary diagnosis of migraine. Patient with a previous diagnosis of migraine, who experience headaches with typical migraine features (e.g at least 2-3 of the following: recurrent, unilateral, pounding or throbbing in nature, associated with nausea), AND with a clinical exclusion of migraine mimics\n\nExclusion Criteria:\n\n* Pregnancy defined as a positive urine HCG\n* Allergy or sensitivity to study drug\n* Stated history of renal insufficiency\n* Documented history of myasthenia gravis\n* Consumption of study drug within 48 hours prior to enrollment\n* Previously enrolled in this trial during a different patient encounter",[79,80],"ADULT","OLDER_ADULT",[82],{"facility":83,"status":8,"city":84,"state":85,"zip":86,"country":87,"contacts":88,"geoPoint":94},"Advocate Christ Medical Center Emergency Department","Oak Lawn","Illinois","60453","United States",[89],{"name":90,"role":91,"phone":92,"email":93},"Samar Ashrafi, PharmD","CONTACT","708-684-7895","samar.ashrafi@aah.org",{"lat":95,"lon":96},41.71087,-87.75811,[98,102],{"name":99,"role":91,"phone":100,"email":101},"Ryan McKillip, MD","708-684-6230","ryan.mckillip@aah.org",{"name":103,"role":91,"phone":104,"email":105},"Marc McDowell, PharmD","708-684-1078","marc.mcdowell@aah.org",[107],{"name":99,"affiliation":13,"role":108},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":112,"biomarkers":113},[19],[],{"nct_id":4,"found":115,"summary":116,"prompt_version":126},true,{"design":117,"status":118,"heading":119,"summary":120,"follow_up":121,"word_count":122,"commitments":123,"compensation":124,"drugs_mentioned":125},"This is a randomized, double-blinded study, meaning participants are randomly assigned to a treatment group and neither you nor your doctors will know which treatment you are receiving. It will compare magnesium plus prochlorperazine to a placebo (inactive substance) plus prochlorperazine.","completed","Magnesium and Prochlorperazine for Migraine Treatment","This study is looking at whether adding magnesium to prochlorperazine (a medicine often used for nausea and migraines) can better reduce migraine pain. You might be able to join if you are 18 or older, can speak English, and have been diagnosed with migraines. The study aims to see how much your pain changes from the start of treatment to 30 minutes after the infusion begins. The current status of this study is unclear, but it plans to enroll 100 people.","The main measurement of pain change is taken from the start of the infusion to 30 minutes after it begins.",81,"Participants will receive prochlorperazine followed by either magnesium or a placebo (normal saline) as an intravenous (IV) infusion.","Not stated in the trial record.",[21],"v2"]