Neurophysiological and Biomolecular Effects of Atogepant in Episodic Migraine
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorIRCCS National Neurological Institute "C. Mondino" Foundation
About this trial
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 criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Atogepant 60 mg
Treatment groups
30 Participants
are divided into 1 treatment groupLocations
1Headache Science & Neurorehabilitation Center27100, PaviaPAVIA, Italy
Sponsors and collaborators
IRCCS National Neurological Institute "C. Mondino" Foundation
Lead sponsor
Source ClinicalTrials.gov