Studies how atogepant affects brain activity and blood markers in migraine
Observes brain and blood changes during atogepant treatment in adults with frequent migraines.
Plain-language title generated from the registry record
Registry title: Neurophysiological and Biomolecular Effects of Atogepant in Episodic Migraine
Key facts
- Where
- Pavia, ItalySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06882122, who can take part
Where in Italy
- Headache Science & Neurorehabilitation CenterPavia, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- IRCCS National Neurological Institute "C. Mondino" Foundation
- Trial code
- NCT06882122
- Record updated
- 18 March 2025
- Original description
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.Read full original descriptionShow less
Neurophysiological and Biomolecular Effects of Atogepant in High Frequency Episodic Migraine (ATOM Project)
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.
Inclusion: 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.
Exclusion: Abuse of alcohol and/or drugs; History of serious psychiatric conditions; Medical conditions considered clinically significant by the investigator; Chronic pain conditions that need chronic treatment; Contraindications to atogepant; Diagnosis of other primary or secondary headaches (only sporadic tension-type headache is allowed); Pregnancy or breastfeeding.