Status:
RECRUITING
Neurophysiological and Biomolecular Effects of Atogepant in Episodic Migraine
Lead Sponsor:
IRCCS National Neurological Institute "C. Mondino" Foundation
Conditions:
Migraine Disorder
Episodic Migraine
Eligibility:
All Genders
18-70 years
Brief Summary
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-...
Detailed Description
BACKGROUND: Migraine is a highly prevalent neurological disease associated to a severe burden for patients and society. Despite recent advances, the knowledge of the molecular and biochemical pathway...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06882122
Start Date
December 1 2024
End Date
April 1 2026
Last Update
March 18 2025
Active Locations (1)
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1
Headache Science & Neurorehabilitation Center
Pavia, PAVIA, Italy, 27100