NCT06882122Recruiting
Neurophysiological and Biomolecular Effects of Atogepant in Episodic Migraine
Neurophysiological and Biomolecular Effects of Atogepant in High Frequency Episodic Migraine (ATOM Project)
Source: ClinicalTrials.gov · Last updated 18 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 11 Mar 2025
- Start date
- 1 Dec 2024
- Primary completion date
- Dec 2025
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" Foundation
- Diseases
- Migraine
- NCT number
- NCT06882122
What you commit to
- Study type: Observational
- Planned participants: 30
- From 1 Dec 2024 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Abuse of alcohol and/or drugs;
Other illness
- History of serious psychiatric conditions;
- Medical conditions considered clinically significant by the investigator;
- Chronic pain conditions that need chronic treatment;
Other
- Contraindications to atogepant;
- Diagnosis of other primary or secondary headaches (only sporadic tension-type headache is allowed);
- Pregnancy or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Headache Science & Neurorehabilitation Center Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.