Effects of Atogepant on Neurophysiology and Biomolecules in Migraine
Neurophysiological and Biomolecular Effects of Atogepant in High Frequency Episodic Migraine (ATOM Project)
This study is testing if a new migraine medication called atogepant can change brain activity and biochemistry in people who have frequent migraines.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | IRCCS National Neurological Institute "C. Mondino" Foundation Academic / other |
| Drugs / interventions | Erenumab |
| Locations | 1 site (Pavia, PAVIA) |
| Trial ID | NCT06882122 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with contraindications to atogepant or those with other significant medical conditions may not benefit from this study.
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 performed: While the approach of using gepants for migraine treatment is relatively new, previous studies have shown promising results in similar contexts.
Eligibility criteria
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 this trial is running
Pavia, PAVIA
- Headache Science & Neurorehabilitation Center — Pavia, Pavia, Italy (Recruiting)
Study contacts
- Study coordinator: Francescantonio Cammarota, MD
- Email: francesco.cammarota@mondino.it
- Phone: 00390382380425
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.