Neurophysiological and Biomolecular Effects of Atogepant in Episodic Migraine
Eligible age
18–70 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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.
Sponsor: IRCCS National Neurological Institute "C. Mondino" Foundation
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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.
Source: ClinicalTrials.gov · NCT06882122 · last updated 2025-03-18