Skip to main content
TTrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor.
RECRUITINGOBSERVATIONAL

Neurophysiological and Biomolecular Effects of Atogepant in Episodic Migraine

Neurophysiological and Biomolecular Effects of Atogepant in High Frequency Episodic Migraine (ATOM Project)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Atogepant 60 mg

Atogepant 60 mg daily for 3 months

Locations (1)

Headache Science & Neurorehabilitation Center
Pavia, PAVIA, Italy