NCT06882122 Neurophysiological and Biomolecular Effects of Atogepant in Episodic Migraine
| NCT ID | NCT06882122 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS National Neurological Institute "C. Mondino" Foundation |
| Condition | Migraine Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2024-12-01 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 (8-14 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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06882122 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Migraine Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06882122 currently recruiting?
Yes, NCT06882122 is actively recruiting participants. Contact the research team at francesco.cammarota@mondino.it for enrollment information.
Where is the NCT06882122 trial being conducted?
This trial is being conducted at Pavia, Italy.
Who is sponsoring the NCT06882122 clinical trial?
NCT06882122 is sponsored by IRCCS National Neurological Institute "C. Mondino" Foundation. The trial plans to enroll 30 participants.
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