Neurophysiological and Biomolecular Effects of Atogepant in Episodic Migraine

Sponsor
IRCCS National Neurological Institute "C. Mondino" Foundation
Study ID
NCT06882122
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Mar 18, 2025
Start date
Dec 1, 2024
Status verified
Mar 2025
Primary completion
Dec 31, 2025
Completion
Apr 30, 2026

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: HFEM group
    High-frequency episodic migraine patients (8-14 migraine days per months) undergoing atogepant 60 mg daily for 3 months

Primary Outcome Measure

Temporal summation threshold of the RIII reflex (continuos variable) [ Time Frame: Baseline (T0) - three months of atogepant 60 mg treatment (T1) ]

Central Contacts

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