RecruitingNCT07035197

Facilitators and Barriers to Eptinezumab Administration in Thailand

Facilitators and Barriers to Eptinezumab Administration in Thailand: Real-World Experiences and Perspectives From Mixed-method Design and In-Depth Interviews (FACEpi)


Sponsor

Chulalongkorn University

Enrollment

30 participants

Start Date

Aug 25, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

This research study is designed as a longitudinal prospective descriptive study using mixed-method data collection. Eptinezumab, an anti-calcitonin gene-related peptide monoclonal antibody (anti-CGRP mAb), is administered by intravenous (IV) infusion every 3 months as preventive medication for individuals with migraine who have been diagnosed based on theInternational Classification of Headache Disorders, 3rd edition (ICHD-3) by headache specialist neurologists. The goal of this study is to understand the real-life experiences of people with migraine who receive eptinezumab in a hospital setting in Thailand, a middle-income country. The researchers want to learn about what makes it easier or harder for patients and healthcare workers to use this treatment. The main questions it aims to answer are: * What are the barriers and facilitators to using eptinezumab from the perspectives of patients and healthcare providers? * Does eptinezumab reduce monthly migraine days and improve quality of life over time? Participants will: * (For migraine patients) Take part in an in-depth interview (IDI) within 24 hours after receiving an eptinezumab infusion * (For migraine patients) Complete questionnaires about migraine symptoms, disability, and quality of life at baseline, 3 months, and 6 months * (For healthcare providers) Take part in a one-time interview about their experiences administering eptinezumab The study will also look at how well eptinezumab works by measuring changes in monthly migraine days and other health scores over a 6-month period. The information from this study may help improve migraine care in Thailand and support better access to new treatments like eptinezumab.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study explores why some migraine patients and healthcare providers in Thailand find it easy — or difficult — to use a preventive migraine injection called eptinezumab, to improve how it's delivered in practice. **You may be eligible if...** (As a patient) - You are 18 years or older - You have been diagnosed with migraine (with or without aura) or chronic migraine - You have received at least one dose of eptinezumab (As a healthcare provider) - You are a doctor, outpatient nurse, or day-care nurse responsible for giving eptinezumab to patients **You may NOT be eligible if...** - You have not received eptinezumab (for patients) - You are not directly involved in eptinezumab administration (for healthcare providers) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEptinezumab

Eptinezumab 100 mg IV q 3 months * Baseline visit: Within 24 hours of receiving eptinezumab (duration of IDI \~30 - 45 minutes) * Semi-structured In-depth interview * MMD (days) * Thai version MIDAS (total score, grading) * Thai version EQ-5D-5L (5 domains \& 5 levels of severity; index score) * 3-month follow-up visits (duration of interview: \~10 minutes): * Semi-structured brief interview * MMD (days) * Thai version MIDAS (total score, grading) * Thai version EQ-5D-5L (5 domains \& 5 levels of severity; index score) * 6-month follow-up visit: * no interview * MMD (days) * Thai version MIDAS (total score, grading) * Thai version EQ-5D-5L (5 domains \& 5 levels of severity; index score)

OTHERSham (No Treatment)

\*\* No intervention, neither eptinezumab nor placebo, was given * Baseline visits: Within 24 hours of giving eptinezumab administration (duration of IDI \~30 - 45 minutes) - Semi-structured in-depth interview


Locations(1)

King Chualongkorn Memorial Hospital, the Thai Red Cross Society

Bangkok, Thailand

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NCT07035197


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