Neurophysiological and Biomolecular Effects of Atogepant in Episodic Migraine
Recruiting now
Conditions studied: Migraine Disorder, Episodic Migraine
In brief
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 facts
- Study ID
- NCT06882122
- Run by
- IRCCS National Neurological Institute "C. Mondino" Foundation
- People needed
- 30
- Starts
- 2024-12-01
- Expected to finish
- 2026-04-01
- Last updated by the study team
- 2025-03-18
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Headache Science & Neurorehabilitation Center — Pavia, PAVIA, Italy (enrolling)
Full record on ClinicalTrials.gov
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