A Phase 4 interventional study of Atogepant 60 mg and Placebo in Migraine Disorders, Brain, Healthy Adult Participants and Vestibulo-Ocular Reflex, sponsored by Konrad Peter Weber. Not yet recruiting at 1 site in Switzerland. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Konrad Peter Weber · Phase 4, Interventional, and Basic science
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Among 21 studies testing atogepant in Migraine Disorders — 6 open to participants now, 7 under way, 4 of them phase 3. atogepant · Migraine Disorders.
Among the 21 studies testing atogepant in Migraine Disorders, this one is the 18th largest by planned enrollment, is the only one that started in 2027, is one of 4 in phase 4, and was the 21st registered.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
Browse Migraine Disorders studies →6 of the 21 studies testing atogepant in Migraine Disorders are open now, in 12 countries. Recruiting first, the newest first:
Mayo Clinic · Sites in United States
Ages 18–70
AbbVie · Sites in United States, Canada, Denmark and 8 more countries
Ages 12–17
AbbVie · Sites in United States, Belgium, Canada and 13 more countries
Ages 6–17
AbbVie · Sites in United States, Belgium, Canada and 13 more countries
Ages 6–17
Stanford University
Ages 18+
By country, each count listing its studies:
atogepant: first FDA approval 2021 (QULIPTA), first EMA approval 2023. What it is approved for, and how studies give it, is on its page →
Of the 217 Migraine Disorders studies recruiting now, 66 (30%) set no upper age limit and 136 (63%) stop at 75 or younger; 44 take children under 18; 37 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
21 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 1 · Phase 3 16 · Phase 4 4
First in 2016; this study’s year is marked. 1 started in 2027.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 80 is close to the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Median enrollment 468 across the 21 interventional studies. Of the 14 that completed or were terminated, 11 (79%) have results posted.
This tab as a report to print or save as PDF → With an account.
18 of 21 have an industry lead sponsor. The 5 most frequent:
This is the only study on the registry with Konrad Peter Weber as lead sponsor.
Konrad Peter Weber has 1 study filed under Migraine Disorders — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 21 studies testing atogepant in Migraine Disorders, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Researchers want to find out how a substance in the body called CGRP affects balance.
CGRP (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.
This 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.
Eighty 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.
Everyone receives both of the following, in random order:
one capsule containing atogepant 60 mg one capsule containing placebo (a capsule with no active medicine)
The 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.
At 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.
A short follow-up visit or telephone call takes place within 7 days after the second test visit.
People 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.
Participants 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.
Background and rationale
Calcitonin gene-related peptide (CGRP) is a neuropeptide with an established role in migraine pathophysiology, and CGRP receptor antagonists (gepants) are approved for migraine treatment and prevention. CGRP is also expressed in the vestibular periphery, where it is released by efferent neurons onto type II hair cells and calyx-bearing afferents. Mice lacking the CGRP gene or the CGRP receptor show reduced VOR gain, indicating that CGRP contributes to the sensitivity of the vestibular afferent response. Whether CGRP receptor antagonism produces a comparable reduction of VOR gain in humans has not been investigated. Because gepants are now widely prescribed, the question is of practical as well as mechanistic relevance, and it may also inform the pathophysiology of vestibular migraine.
Objective
The trial investigates whether acute pharmacological blockade of the CGRP receptor reduces the gain of the vestibulo-ocular reflex in humans. Semicircular canal function is assessed across the frequency spectrum (video head impulse test, caloric irrigation, sinusoidal harmonic acceleration on the rotary chair) and otolith function is assessed by the ocular counter-torsion response to static whole-body tilt. Prepulse inhibition of the blink reflex is assessed as an additional brainstem excitability measure.
Design
Single-centre, randomised, placebo-controlled, double-blind, two-period cross-over trial conducted in two consecutive phases: 40 healthy participants are enrolled first, and recruitment of 40 participants with episodic or chronic migraine (ICHD-3) begins only once enrolment in the healthy group is complete. Total enrolment is 80.
Each participant attends a screening visit (Visit 0, up to 28 days before or on the same day as Visit 1), two treatment visits (Visits 1 and 2) separated by a washout period of at least 5 days, and a safety follow-up (Visit 3) within 7 days after Visit 2. Each treatment visit lasts approximately 165 minutes.
Randomisation and blinding
Participants are randomised 1:1 to treatment sequence AB (atogepant at Visit 1, placebo at Visit 2) or BA. The allocation sequence is computer-generated with permuted blocks of variable length, stratified by group, by a physician independent of the study team who holds the random seed, the block lengths and the master code list and who releases the list only after database lock. Blinded kits are prepared and labelled to that sequence by an independent pharmacy. Participants, the sponsor-investigator, the sub-investigators, the study staff, the statistician and the monitor all remain blinded. One sealed code-break envelope per participant is held at the site for emergency unblinding.
Intervention
A single oral dose of atogepant 60 mg, or matching placebo, is administered under direct supervision at each treatment visit. To preserve the blind, the marketed film-coated tablet is over-encapsulated in a size 000 hard-gelatine capsule filled with mannitol; the placebo capsule contains mannitol only and is identical in appearance. The 5-day washout exceeds ten elimination half-lives of atogepant (t½ ≈ 11 h). Vestibular testing begins 90-120 minutes after dosing, and participants remain under observation at the site for at least 90 minutes after each dose.
Statistical analysis
The primary null hypothesis is that the mean intra-individual difference in VOR gain between the atogepant and placebo conditions is zero, tested two-sided at α = 0.05. Analyses use paired t-tests and repeated-measures ANOVA for within-group comparisons and mixed-effects models for comparisons between the healthy and migraine groups, accounting for the cross-over design. Sex is included as a covariate.
Oversight
Investigator-initiated trial, Category B under the Swiss Clinical Trials Ordinance. No Data Monitoring Committee is established; the rationale is given in the protocol. Risk-adapted monitoring is performed by an independent, blinded monitor.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Healthy participants (Phase 1 of enrolment):
Participants with migraine (Phase 2 of enrolment):
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Atogepant; Drug: Placebo
Drug: Atogepant 60 mg · Drug: Placebo
Drug: Placebo; Drug: Atogepant
Drug: Atogepant 60 mg · Drug: Placebo
Single oral dose of atogepant 60 mg, administered once during the trial. The marketed Aquipta® 60 mg film-coated tablet, authorised in Switzerland, is over-encapsulated into a size 000 hard-gelatine capsule filled with mannitol (Ph. Eur.) by an independent pharmacy in order to maintain blinding; the active substance and the tablet itself are not modified. The capsule is swallowed with a glass of water under the direct supervision of the investigator, and the date and time of administration are documented.
Also known as: Aquipta, Qulipta
Sequence AB: Atogepant then Placebo · Sequence BA: Placebo then Atogepant
Change in vestibulo-ocular reflex (VOR) gain measured by video head impulse test (vHIT)
VOR gain of the horizontal semicircular canals, measured by video head impulse test as the ratio of eye velocity to head velocity (unitless), under atogepant 60 mg compared with placebo. The intra-individual difference between the atogepant condition and the placebo condition is the quantity of interest. A difference of 0.10 in VOR gain is considered clinically meaningful.
Time frame: Assessed 90-120 minutes after dosing in each of the two treatment periods (Visit 1 and Visit 2, separated by a washout of at least 5 days)
Caloric response
Total caloric response, calculated as the sum of the peak slow-phase eye velocities (°/s) of the four irrigations (warm and cool, left and right ear), under atogepant 60 mg compared with placebo.
Time frame: Assessed 90-120 minutes after dosing in each of the two treatment periods (Visit 1 and Visit 2, separated by a washout of at least 5 days)
Rotary chair VOR gain (sinusoidal harmonic acceleration)
VOR gain during sinusoidal harmonic acceleration on the rotary chair (ratio of eye velocity to chair velocity, unitless), measured across the frequency range 0.01-0.5 Hz, under atogepant 60 mg compared with placebo.
Time frame: Assessed 90-120 minutes after dosing in each of the two treatment periods (Visit 1 and Visit 2, separated by a washout of at least 5 days)
Nausea assessed by visual analogue scale
Description: Severity of nausea, assessed on a 100 mm visual analogue scale anchored at "no nausea" (0 mm) and "worst imaginable nausea" (100 mm), with higher scores indicating more severe nausea. The change from before to after the vestibular test battery is compared between the atogepant 60 mg condition and the placebo condition.
Time frame: Immediately before and immediately after the vestibular test battery at each of the two treatment visits (approximately 90 and 180 minutes after dosing)
Motion sickness symptoms assessed by the Motion Sickness Assessment Questionnaire (MSAQ)
Motion sickness symptoms following caloric and rotary chair testing, assessed with the Motion Sickness Assessment Questionnaire (MSAQ). The MSAQ total score is reported as a percentage of the maximum possible score, with higher scores indicating more severe symptoms. The change from before to after the vestibular test battery is compared between the atogepant 60 mg condition and the placebo condition.
Time frame: Immediately before and immediately after the vestibular test battery at each of the two treatment visits (approximately 90 and 180 minutes after dosing)
Spinning vertigo assessed by visual analogue scale
Severity of spinning vertigo, assessed on a 100 mm visual analogue scale anchored at "no spinning vertigo" (0 mm) and "worst imaginable spinning vertigo" (100 mm), with higher scores indicating more severe vertigo. The change from before to after the vestibular test battery is compared between the atogepant 60 mg condition and the placebo condition.
Time frame: Immediately before and immediately after the vestibular test battery at each of the two treatment visits (approximately 90 and 180 minutes after dosing)
VOR latency
Latency (milliseconds) between the onset of the head movement and the onset of the compensatory eye movement during video head impulse testing, under atogepant 60 mg compared with placebo.
Time frame: Assessed 90-120 minutes after dosing in each of the two treatment periods (Visit 1 and Visit 2, separated by a washout of at least 5 days)
Compensatory saccades
Presence and characteristics of compensatory overt and covert saccades during video head impulse testing, under atogepant 60 mg compared with placebo.
Time frame: Assessed 90-120 minutes after dosing in each of the two treatment periods (Visit 1 and Visit 2, separated by a washout of at least 5 days)
Prepulse inhibition of the blink reflex
Prepulse inhibition of the blink reflex, expressed as the percentage reduction of the blink reflex response amplitude when preceded by a prepulse stimulus, under atogepant 60 mg compared with placebo.
Time frame: Time Frame: 90-150 minutes after dosing in each treatment period.
Plan to share: No — Individual participant data will not be shared. The participant information and informed consent form for this investigator-initiated, single-centre trial do not cover the further use of the collected data for research purposes beyond this project, and under the Swiss Human Research Act data may not be shared for purposes that are not covered by the participants' consent. In addition, the dataset is small (80 participants from a single centre) and contains detailed oculomotor and clinical measurements, so a meaningful risk of re-identification would remain after de-identification.
Start is estimated for Jan 2027; primary completion for Dec 2028, 23 months later.
Of 49 non-industry phase 4 interventional studies under Migraine Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 51. This study's planned 23 months is below that.
Counting every sponsor, half of 77 studies reached it within 27 months; a quarter within 17 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Atogepant