Actively Recruiting

Age: 18Years - 70Years
All Genders
NCT06882122

Neurophysiological and Biomolecular Effects of Atogepant in Episodic Migraine

Led by IRCCS National Neurological Institute "C. Mondino" Foundation · Updated on 2025-03-18

30

Participants Needed

1

Research Sites

69 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Neurophysiological and Biomolecular Effects of Atogepant in Episodic Migraine

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 naive to CGRP-targeted treatments
  • No more than one ongoing migraine preventive treatment with a stable dose for at least 3 months
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Headache Science & Neurorehabilitation Center

Pavia, PAVIA, Italy, 27100

Actively Recruiting

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Research Team

F

Francescantonio Cammarota, MD

CONTACT

C

Cinzia Fattore

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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