Neurophysiological and Biomolecular Effects of Atogepant in Episodic Migraine
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorIRCCS National Neurological Institute "C. Mondino" Foundation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial population
Subjects with high frequency episodic migraine attending the outpatient clinic of the Headache Science \& Neurorehabilitation Center of the IRCCS Mondino Foundation (Pavia, Italy).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Atogepant 60 mg
DrugAtogepant 60 mg daily for 3 months
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: HFEM group1 intervention
Trial outcomes
Primary outcomes
1
Temporal summation threshold of the RIII reflex (continuos variable)
Temporal summation threshold of the RIII reflex will be used to assess central sensitization after 3 months of treatment with atogepant 60 mg/day compared to baseline.
Time frame
Baseline (T0) - three months of atogepant 60 mg treatment (T1)2
MAGL gene expression (continuos variable)
Changes in MAGL gene expression after 3 months of treatment with atogepant 60 mg/day
Time frame
Baseline (T0) - three months of atogepant 60 mg treatment (T1)Secondary outcomes
1
Habituation index of the nociceptive Blink Reflex (continuous variable)
"Habituation index" of the nociceptive Blink Reflex will be used to evaluate difference in brainstem habituation after three months of treatment with atogepant 60mg.
Time frame
Baseline (T0) - three months of atogepant 60 mg treatment (T1)2
Habituation of the visual evoked potential (continuous variable)
Habituation of the visual evoked potential, assessed through P100 amplitude between the last and first block, will be used to assess changes in cortical habituation after three months of atogepant
Time frame
Baseline (T0) - three months of atogepant 60 mg treatment (T1)3
Functional brain connectivity (continuous variable)
Changes in functional brain connectivity, assessed through HD-EEG after 3 months of treatment with atogepant 60 mg/day.
Time frame
Baseline (T0) - three months of atogepant 60 mg treatment (T1)4
FAAH gene expression (continuous variable)
Changes in FAAH gene expression after 3 months of treatment with atogepant 60 mg/day.
Time frame
Baseline (T0) - three months of atogepant 60 mg treatment (T1)Sponsors and contacts
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Source ClinicalTrials.gov