[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vestibulo-ocular-reflex\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vestibulo-ocular-reflex":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":32,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":5},"100656385","phase-4-effect-of-atogepant-on-the-vestibulo-ocular-reflex-in-healthy-adults-and-adults-with-migraine-100656385",false,"NCT07826910","Effect of Atogepant on the Vestibulo-Ocular Reflex in Healthy Adults and Adults With Migraine","The Role of CGRP in Human Vestibulo-Ocular Reflex (VOR) - a Randomized, Blinded, Placebo-controlled, Cross-over Trial","VOR-GRIP","Inclusion Criteria:\n\nHealthy participants (Phase 1 of enrolment):\n\n* Age 18 to 65 years\n* No functional or structural vestibular disorder\n* No history of unilateral or bilateral vestibulopathy\n* No diagnosis of migraine\n* Written informed consent provided by the participant\n\nParticipants with migraine (Phase 2 of enrolment):\n\n* Diagnosis of episodic or chronic migraine according to the ICHD-3 criteria\n* Age 18 to 65 years\n* No functional or structural vestibular disorder\n* No history of unilateral or bilateral vestibulopathy\n* Written informed consent provided by the participant\n\nExclusion Criteria:\n\n* Hypersensitivity to atogepant\n* Intake of any CGRP-antagonist medication within the last 6 months\n* Known impaired kidney function with a creatinine clearance below 30 mL\u002Fmin, or known impaired liver function (Child-Pugh B or C)\n* Insufficiently controlled, unstable or newly diagnosed cardiovascular disease, for example ischaemic coronary disease, coronary vasospasm or cerebral ischaemia\n* Myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, cardiac surgery, stroke of any kind or transient ischaemic attack within the last 6 months (24 weeks)\n* Medication overuse headache\n* Cardiac pacemaker or other implanted electronic device\n* Concomitant use of strong CYP3A4 inhibitors, of strong or moderate CYP3A4 inducers, or of OATP1B1\u002FOATP1B3 inhibitors\n* Pregnancy or breastfeeding; women of childbearing potential not using effective contraception during the study\n* Participation in another clinical trial with an investigational medicinal product within 30 days before the screening visit\n* Inability to understand the participant information or to give written informed consent",true,"ALL","18 Years","65 Years",{"count":22,"type":23},80,"ESTIMATED","INTERVENTIONAL",[26],"PHASE4","Researchers want to find out how a substance in the body called CGRP affects balance.\n\nCGRP (calcitonin gene-related peptide) is a small protein involved in migraine. Several approved migraine medicines work by blocking it. Studies in animals suggest that CGRP also helps a reflex called the vestibulo-ocular reflex, or VOR. The VOR keeps vision steady when the head moves: when the head turns, the eyes move the opposite way by the same amount, so the world does not appear to jump. Animals that lack the CGRP receptor have a weaker VOR. It is not known whether blocking CGRP weakens the VOR in people.\n\nThis study tests whether a single dose of atogepant changes the VOR in people. Atogepant is approved in Switzerland for the prevention of migraine and blocks the CGRP receptor. In this study it is used in a different way than it is approved for.\n\nEighty people will take part at the University Hospital Zurich. The study runs in two parts. First, 40 healthy people join. After that, 40 people who have episodic or chronic migraine join.\n\nEveryone receives both of the following, in random order:\n\none capsule containing atogepant 60 mg one capsule containing placebo (a capsule with no active medicine)\n\nThe two test visits are at least 5 days apart. A computer decides which capsule each person receives first. Neither the participants nor the study team know which capsule is which until the study is finished.\n\nAt each test visit, the participant swallows the capsule at the study centre and stays for at least 90 minutes. Balance and eye-movement tests then begin, about 90 to 120 minutes after the capsule. The tests record eye movements while the head is moved quickly, while warm and cool air or water is placed in the ear canal, while a chair turns gently from side to side, and while the whole body is tilted. Participants also answer short questionnaires about nausea and dizziness before and after the tests. Each test visit lasts about 2 hours and 45 minutes.\n\nA short follow-up visit or telephone call takes place within 7 days after the second test visit.\n\nPeople aged 18 to 65 can take part if they have no balance disorder and meet the other study requirements. People cannot take part if, for example, they are allergic to atogepant, have taken a CGRP-blocking medicine in the past 6 months, have severe kidney or liver problems, have unstable heart disease, have a pacemaker, or are pregnant or breastfeeding.\n\nParticipants are not expected to get a health benefit from taking part. The study is done to learn more about how CGRP works in the balance system, which may help in developing treatments for dizziness and migraine in the future.",[29,30,31],"Migraine Disorders, Brain","Healthy Adult Participants","Vestibulo-Ocular Reflex",[33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51],"CGRP","Calcitonin Gene-Related Peptide","CGRP receptor antagonist","Gepant","Atogepant","Vestibulo-ocular reflex","VOR gain","Vestibular function","Otolith function","Video head impulse test","vHIT","Caloric testing","Rotary chair","Sinusoidal harmonic acceleration","Prepulse inhibition","Blink reflex","Cross-over study","Healthy volunteers","Migraine","NOT_YET_RECRUITING","2026-09-16",{"date":55,"type":56},"2026-09-17","ACTUAL",{"date":58,"type":23},"2027-01-01",{"date":60,"type":23},"2028-12",{"name":62,"class":63},"Konrad Peter Weber","OTHER"]