Clinical trial Recruiting at 1 site Observational Ages 18 to 70

Effects of Atogepant on Neurophysiology and Biomolecules in Migraine

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

Run by IRCCS National Neurological Institute "C. Mondino" Foundation · NCT06882122 · Data updated 2026-11-12

This study is testing if a new migraine medication called atogepant can change brain activity and biochemistry in people who have frequent migraines.

More Episodic Migraine trials

Quick facts

Study typeObservational
Ages18 Years to 70 Years
SexAll
Enrollment30 (estimated)
SponsorIRCCS National Neurological Institute "C. Mondino" Foundation
Academic / other
Drugs / interventionsErenumab
Locations1 site (Pavia, PAVIA)
StatusRecruiting
StartedDecember 1, 2024
Main results expectedDecember 2025
Study endsApril 2026
Registry record updatedMarch 18, 2025
Trial IDNCT06882122 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 to 70 with a diagnosis of high-frequency episodic migraine and who have not previously received CGRP-targeted treatments.

Probably not a fit

Patients with contraindications to atogepant or those with other significant medical conditions may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the neurophysiological and biochemical changes resulting from a 3-month treatment with atogepant in patients experiencing high-frequency episodic migraines. Participants will undergo various assessments, including High-Density EEG and biomolecular profiling, to understand the drug's impact on brain connectivity and migraine pathways. The findings will help identify predictors of treatment response and explore alternative therapeutic targets for those who do not respond to atogepant.

Why it matters

Potential benefit: If successful, this study could lead to more personalized and effective treatment options for patients suffering from episodic migraines.

How similar studies have gone: While the approach of using gepants for migraine treatment is relatively new, previous studies have shown promising results in similar contexts.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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 Criteria:

* 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's running

  • Headache Science & Neurorehabilitation Center
    Pavia, Pavia, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  • Yoga-based Movements for Primary Headaches (YOURHEAD)

    A yoga-based movement program is being tested to see if it can help reduce headaches and improve quality of life for adults with migraine and/or cluster headaches.

    Recruiting Karolinska Institutet · Huddinge · NCT07348783

  • Real-world use of anti-CGRP medicines for preventing migraine

    This project will follow people with episodic or chronic migraine who start anti-CGRP medicines to see if the treatments reduce migraine frequency and side effects over two years.

    Recruiting at 25 sites Hospital Universitari Vall d'Hebron Research Institute · Miami, Florida and 25 other locations · NCT07159750

  • i-NEED: New migraine drugs database

    This project will collect real-life data to see how new migraine treatments—anti‑CGRP antibodies, gepants, ditans, and a sumatriptan‑naproxen combo—work and how well adults with episodic or chronic migraine tolerate them.

    Recruiting at 2 sites IRCCS San Raffaele Roma · Milan, Italy and 1 other locations · NCT07103694

  • Tai Chi vs acupuncture for migraine prevention and brain changes

    This trial tests whether Tai Chi or acupuncture can reduce migraine attacks in Chinese women and whether either approach changes brain structure.

    Recruiting The Hong Kong Polytechnic University · Hung Hom · NCT06967909

  • Aerobic exercise to improve sensory, muscle, and psychosocial symptoms in women with migraine

    This trial will test whether supervised aerobic exercise plus one pain neuroscience education session helps women aged 18–48 with migraine reduce disability and improve sensory, musculoskeletal, and psychosocial symptoms.

    Recruiting University of Sao Paulo · Ribeirão Preto, São Paulo · NCT06716489

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.