[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-migraine\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-migraine":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,39],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100644816","phase-3-a-long-term-safety-study-of-elismetrep-k-304-in-the-acute-treatment-of-migraine-100644816",false,"NCT07674654","A Long-Term Safety Study of Elismetrep (K-304) in the Acute Treatment of Migraine","Inclusion Criteria:\n\n1. Participant completing an acute treatment trial of elismetrep (Study K-304 P003; attending the EoS Visit 3 within the allowed visit window of the acute treatment study), treated a qualifying migraine in that study, was at least 80% compliant with the daily e-Diary 'check-ins' in the base study and completed the 2-hour and 4-hour post-dose assessments in the eDiary;\n2. Participant voluntarily agrees to participate in the study by giving written informed consent;\n3. Participant is able to read, understand, and complete the study questionnaires and diary;\n4. Participant is willing and able to comply with the study schedule of visits, all trial procedures and restrictions;\n5. Participant is willing to use his\u002Fher own personal, qualified smartphone to download any specific eDiary applications for use for the entire duration of the study;\n6. For females of reproductive potential (as determined in the base study), continues to agree to remain abstinent from heterosexual activity or a. Agrees to use (or have their partner use) a birth control method that is acceptable from the first dose of study drug until the EoS visit.\n\nAcceptable methods of birth control are:\n\ni. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal. ii. Progestogen-only hormonal contraception associated with inhibition of ovulation: oral; injectable; implantable; intrauterine device; intrauterine hormone-releasing system; bilateral tubal occlusion; vasectomized partner; sexual abstinence\\*; progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action; male or female condom with or without spermicide; cap, diaphragm or sponge with spermicide; a combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods).\n\n* Abstinence can be used as the sole method of contraception if it is in line with the participant's preferred and usual lifestyle and if considered acceptable by local regulatory agencies and ethics committees. Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, post-ovulation methods, etc.) and withdrawal are not acceptable methods of contraception.\n\nExclusion Criteria:\n\n1. Is a female who is pregnant, breast-feeding, or intends to become pregnant during the planned course of the study. Note: Participants must have a negative urine pregnancy result at the base study EoS\u002FVisit 3 (i.e., pre-randomization for this study);\n2. Has, at the time of the base study EoS\u002FVisit 3, had any change in medical history or a laboratory finding since screening in the acute treatment study that in the opinion of the investigator renders the participant unsuitable for this study (e.g., development of a finding that would have precluded participation in the base acute treatment study);\n3. Participant is at imminent risk of self-harm, based on clinical interview and responses on the Columbia Suicidality Severity Rating Scale (C-SSRS) taken during the base study E0S\u002FVisit 3, or of harm to others in the opinion of the investigator. Participants must be excluded if they report suicidal ideation with intent, with or without a plan (i.e., Type 4 or 5 on the C-SSRS) in 'since last version' version of the C-SSRS;\n4. Participant is currently in violation of study requirements for prohibited and permissible concomitant medications (not already specified in other criteria or is anticipated to violate these requirements during trial participation) as assessed for the base study E0S\u002FVisit 3;\n5. Has any major surgery scheduled for the duration of the trial;\n6. Has any other unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize the participant's safety or compliance with the protocol, or otherwise interfere with the interpretation of efficacy and\u002For safety results;\n7. At Visit 1, has an open\u002Fongoing adverse event from the base study EoS visit;\n8. Experienced a serious adverse event in the base study;\n9. Has previous participation in this trial. Participation is defined as signed informed consent following completion of the base study EoS\u002FVisit 3 procedures.","ALL","18 Years",{"count":18,"type":19},1000,"ESTIMATED","INTERVENTIONAL",[22],"PHASE3","This is a long-term safety study to evaluate the safety and tolerability of intermittent use of elismetrep in the acute treatment of migraine attacks.",[25],"Acute Migraine","NOT_YET_RECRUITING","2026-06-30",{"date":29,"type":30},"2026-07-02","ACTUAL",{"date":32,"type":19},"2026-07",{"date":34,"type":19},"2028-06",{"name":36,"class":37},"Kallyope Inc.","INDUSTRY",115,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":46,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":20,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":63,"leadSponsor":65,"locationsCount":68},"100643927","phase-1-a-prospective-open-label-study-evaluating-the-effectiveness-of-gepants-for-acute-treatment-of-migraine-in-the-emergency-department-100643927","NCT07667621","A Prospective, Open-Label Study Evaluating the Effectiveness of Gepants for Acute Treatment of Migraine in the Emergency Department","A Prospective, Open-Label Study Evaluating the Effectiveness of Rimegepant ODT or Zavegepant Nasal Spray for Acute Treatment of Migraine in the Emergency Department","Inclusion Criteria:\n\n* • At least 18 years of age\n\n  * Capacity to provide informed consent (without a Representative)\n  * Emergency Department presentation for a headache consistent with migraine, based either on the treating clinical team's judgement, or fulfillment of International Classification of Headache Disorders (ICHD-3) criteria for migraine without aura or with typical aura, or for probable migraine without aura or with typical aura. It is acceptable if current headache duration is \\>72 hours. Must have been headache free for \\>48 hours prior to current attack.\n  * Willing to participate in post-discharge telephone assessments\n  * English and\u002For Spanish speaking patients\n\nExclusion Criteria:\n\n* • Use of intranasal decongestants within 1 hour prior to study drug administration, due to the potential to decrease absorption of intranasal zavegepant.\n\n  * Use of analgesics or abortive headache medications within 60 minutes of study medication administration\n  * Use of the following drug\u002Ffood categories with potential for drug interactions within 7 days or 5 half-lives, whichever is longer: 1) CYP3A strong or moderate inducers, 2) CYP3A4 strong inhibitors, 3) P-glycoprotein (P-gp) inhibitors, 4) OATP1B3 transporter potent inhibitors\u002Finducers, 5) NTCP transporter potent inhibitors\u002Finducers\n  * History of ischemic cardiovascular disease, diabetes, or hypertension (diagnosed or likely based on multiple readings), that was recently diagnosed within 3 months of screening or is currently uncontrolled or unstable\n  * History of any stroke within 3 months, or any lifetime stroke and age ≥65 years\n  * History of significant peripheral vascular disease, as assessed by the investigator or qualified delegate\n  * History of Raynaud's Phenomenon (medically diagnosed, or non-medically diagnosed with affirmative responses to both unusual sensitivity and finger color change with cold exposure)\n  * History of severe hepatic impairment, as assessed by the investigator or qualified delegate\n  * History of kidney disease stage 4 (eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2)\n  * History of hypersensitivity reaction to rimegepant, zavegepant, or to any included inactive ingredients\n  * Lifetime use of CGRP-targeting acute or preventive migraine medications\n  * In custody of law enforcement\n  * Current pregnancy or lactation\n\n    * All individuals of childbearing potential must have a negative pregnancy test at screening (urine or serum).\n    * A person is considered to be of childbearing potential if possessing female reproductive organs at birth, post-menarchal, has not reached a post-menopausal state (≥12 continuous months of amenorrhea with no cause identified other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis).",true,{"count":48,"type":19},100,[50],"PHASE1","Prospective, single-site, open-label, non-controlled pilot study consisting of two parallel trials. Participants will receive rimegepant or zavegepant for acute migraine treatment during a single Emergency Department visit, with post-discharge follow-up through 28 days. Participants will be allocated to either the rimegepant trial or the zavegepant trial. The study design does not include a placebo or active comparator control group, and the two gepant study drugs are not designed to function as active comparator groups. The objective in this investigation is to examine relief from either rimegepant or zavegepant in separate parallel trials.",[53,54,55,56,25,57,58],"Migraine","Migraine Disease","Migraine in Adults","Migraine Headache","Migraine Without Aura","Migraine With Aura","2026-06-20",{"date":61,"type":30},"2026-06-25",{"date":32,"type":19},{"date":64,"type":19},"2027-08",{"name":66,"class":67},"University of South Florida","OTHER",1]