Neurophysiological and Biomolecular Effects of Atogepant in Episodic Migraine (NCT06882122) | Clinical Trial Compass
RecruitingNot Applicable
Neurophysiological and Biomolecular Effects of Atogepant in Episodic Migraine
Italy30 participantsStarted 2024-12-01
Plain-language summary
The investigators aim to assess and compare neurophysiological and biochemical changes induced by a 3-month treatment with atogepant (60 mg daily) in patients with high-frequency episodic migraine (8-14 monthly migraine days). Evaluations will include neurophysiological assessments (High-Density EEG, nociceptive reflexes, and visual evoked potentials) and biomolecular profiling (gene expression of endocannabinoid catabolizing enzymes, CGRP and PACAP plasma levels, and headache-specific microRNAs). Outputs will contribute to defining predictors of atogepant response, elucidating its effects on brain connectivity, excitability, and CGRP/endocannabinoid pathways, and identifying alternative therapeutic targets for non-responders.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Individuals aged between 18 and 70;
* Diagnosis of episodic migraine according to ICHD-3 criteria;
* Monthly migraine days between 8 and 14 (high-frequency episodic migraine pattern) in the 3 months before screening;
* Individuals naïve to CGRP-targeted treatments;
* No more than one ongoing migraine preventive treatment with a stable dose for at least 3 months.
Exclusion Criteria:
* Contraindications to atogepant;
* History of serious psychiatric conditions;
* Diagnosis of other primary or secondary headaches (only sporadic tension-type headache is allowed);
* Medical conditions considered clinically significant by the investigator;
* Chronic pain conditions that need chronic treatment;
* Abuse of alcohol and/or drugs;
* Pregnancy or breastfeeding.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Temporal summation threshold of the RIII reflex (continuos variable)
Timeframe: Baseline (T0) - three months of atogepant 60 mg treatment (T1)
2
MAGL gene expression (continuos variable)
Timeframe: Baseline (T0) - three months of atogepant 60 mg treatment (T1)
Trial details
NCT IDNCT06882122
SponsorIRCCS National Neurological Institute "C. Mondino" Foundation