Actively Recruiting
Neurophysiological and Biomolecular Effects of Atogepant in Episodic Migraine
Led by IRCCS National Neurological Institute "C. Mondino" Foundation · Updated on 2025-03-18
30
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neurophysiological and Biomolecular Effects of Atogepant in Episodic Migraine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 naive to CGRP-targeted treatments
- No more than one ongoing migraine preventive treatment with a stable dose for at least 3 months
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Headache Science & Neurorehabilitation Center
Pavia, PAVIA, Italy, 27100
Actively Recruiting
Research Team
F
Francescantonio Cammarota, MD
CONTACT
C
Cinzia Fattore
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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