Neurophysiological and Biomolecular Effects of Atogepant in Episodic Migraine
Recruiting · NCT06882122 · Observational (researchers observe without assigning treatment) · Lead sponsor: IRCCS National Neurological Institute "C. Mondino" Foundation
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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.
Where it is running
1 location listed.
- Headache Science & Neurorehabilitation Center - Pavia, PAVIA, Italy