Studies how atogepant affects brain activity and blood markers in migraine
Observes brain and blood changes during atogepant treatment in adults with frequent migraines.
Key facts
- Who runs it
- IRCCS National Neurological Institute "C. Mondino" Foundation
- Where
- Pavia, ItalySee the site
- Trial code
- Registry title
- Neurophysiological and Biomolecular Effects of Atogepant in Episodic Migraine
- Status
- Recruiting
- People taking part
- 30 people, planned
- Started
- 1 Dec 2024
- Planned end
- Apr 2026
- Type of study
- Observational
- Treatments tested
- Atogepant 60 mg
- Record updated
- 18 March 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 70 with episodic migraine who have 8 to 14 migraine days a month and have never had CGRP-targeted treatment.
- Age
- 18 to 70 years
- Sex
- All sexes can join.
- Disease stage
- Episodic migraine (ICHD-3 criteria) with 8 to 14 monthly migraine days in the 3 months before screening (high-frequency episodic migraine).
- Earlier treatment
- Must never have had CGRP-targeted treatment. No more than one ongoing migraine preventive treatment, at a stable dose for at least 3 months.
Main reasons for not taking part
- Contraindications to atogepant
- History of serious psychiatric conditions
- Other primary or secondary headaches (only sporadic tension-type headache is allowed)
- Chronic pain conditions that need chronic treatment
- Pregnancy or breastfeeding
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
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?
Where in Italy
- Headache Science & Neurorehabilitation CenterPavia, ItalyContact: Francescantonio CammarotaTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- HFEM group
High-frequency episodic migraine patients (8-14 migraine days per months) undergoing atogepant 60 mg daily for 3 months
Treatment: Atogepant 60 mg
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Neurophysiological and Biomolecular Effects of Atogepant in High Frequency Episodic Migraine (ATOM Project)
- Plain-language title
- Studies how atogepant affects brain activity and blood markers in migraineGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06882122, who can take part
- Record updated
- 18 March 2025