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Neurophysiological and Biomolecular Effects of Atogepant in Episodic Migraine

Recruitingn/aAges 18 Years - 70 YearsAllIRCCS National Neurological Institute "C. Mondino…
NCT06882122 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Atogepant 60 mg
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Where

1 site
Headache Science & Neurorehabilitation Center
Pavia, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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