Neurophysiological and Biomolecular Effects of Atogepant in Episodic Migraine
Neurophysiological and Biomolecular Effects of Atogepant in High Frequency Episodic Migraine (ATOM Project)
IRCCS National Neurological Institute "C. Mondino" Foundation
30 participants
Dec 1, 2024
OBSERVATIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria7
- 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.
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Interventions
Atogepant 60 mg daily for 3 months
Locations(1)
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NCT06882122