Neurophysiological and Biomolecular Effects of Atogepant in Episodic Migraine
Launched by IRCCS NATIONAL NEUROLOGICAL INSTITUTE "C. MONDINO" FOUNDATION · Mar 11, 2025
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of a medication called atogepant on people who experience high-frequency episodic migraines, which means they have 8 to 14 migraine days each month. The researchers want to understand how atogepant affects the brain and body over three months by measuring changes in brain activity and certain biological markers in the blood. This information could help identify who benefits most from the treatment and explore new ways to help those who don’t respond to current migraine therapies.
To participate in the trial, individuals need to be between 18 and 70 years old and have a diagnosis of episodic migraine. They should experience 8 to 14 migraine days a month and not have used certain other migraine treatments before. Participants will take atogepant daily and undergo various tests to track their progress. It's essential to note that individuals with certain medical conditions or those who are pregnant or breastfeeding cannot join the study. This trial is currently recruiting participants, and it offers a chance to contribute to valuable research aimed at improving migraine treatment.
Gender
ALL
Eligibility 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.
About Irccs National Neurological Institute "C. Mondino" Foundation
The IRCCS National Neurological Institute "C. Mondino" Foundation is a prominent research institution in Italy dedicated to advancing the field of neurology through innovative clinical trials and scientific research. As a recognized IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico), the foundation focuses on the diagnosis, treatment, and rehabilitation of neurological disorders, fostering collaboration among healthcare professionals, researchers, and academic institutions. Committed to translating cutting-edge research into clinical practice, the foundation aims to enhance patient care and improve outcomes for individuals affected by neurological diseases. Its rigorous approach to clinical trials ensures the highest standards of scientific integrity and patient safety.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Pavia, , Italy
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported