Atogepant 60 mg: Atogepant 60 mg daily for 3 months
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Temporal summation threshold of the RIII reflex (continuos variable) — Baseline (T0) - three months of atogepant 60 mg treatment (T1) Temporal summation threshold of the RIII reflex will be used to assess central sensitization after 3 months of treatment with atogepant 60 mg/day compared to baseline.
MAGL gene expression (continuos variable) — Baseline (T0) - three months of atogepant 60 mg treatment (T1) Changes in MAGL gene expression after 3 months of treatment with atogepant 60 mg/day
Trial sites (1)
Facility
City
Region
Status
Headache Science & Neurorehabilitation Center
Pavia
PAVIA
Recruiting
More IRCCS National Neurological Institute "C. Mondino" Foundation trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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