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

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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