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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Headache Science & Neurorehabilitation Center
RECRUITING
Pavia
Contact Information
Primary
Francescantonio Cammarota, MD
francesco.cammarota@mondino.it
00390382380425
Backup
Cinzia Fattore
cinzia.fattore@mondino.it
00390382380385
Time Frame
Start Date: 2024-12-01
Estimated Completion Date: 2026-04
Participants
Target number of participants: 30
Treatments
HFEM group
High-frequency episodic migraine patients (8-14 migraine days per months) undergoing atogepant 60 mg daily for 3 months
Related Therapeutic Areas
Sponsors
Leads: IRCCS National Neurological Institute C. Mondino Foundation

This content was sourced from clinicaltrials.gov