NCT07035197

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Chulalongkorn University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study explores how people with migraine in Thailand experience treatment with eptinezumab, a anti-CGRP mAb given through an IV infusion every 12 weeks to help prevent migraine attacks. While this medicine may work quickly and avoid skin irritation from injections, it must be given at a hospital, which may cause challenges for patients and healthcare providers. These challenges can include travel, time, cost, or extra work for hospital staff. The study, called FACEpi, will look at what makes eptinezumab easy or hard to use in real life. It will gather views from both people with migraine and the healthcare professionals who provide the treatment. Researchers want to better understand how patients feel about this treatment and how it affects their daily life. About 30 participants will join the study from the Headache Clinic and Daycare Ward at King Chulalongkorn Memorial Hospital (KCMH). These include adults with migraine (10 participants who have never recieved anti-CGRP mAb and 10 participants who have recieved anti-CGRP mAb) and 10 healthcare providers including doctors, nurses, nurse aids, etc. who give eptinezumab in our hospital. Each patient will take part in a semi-structured interview shortly after receiving eptinezumab and complete short surveys about migraine symptoms, migraine headache day (MHD), migraine disability (MIDAS), and quality of life (Euro-Quality of Life version EQ-5D-5L) at three time points: within 24 hours after treatment, after 3 months, and after 6 months. Healthcare providers will complete a one-time interview to talk about their experiences giving the treatment. The main goals of this study are: * To understand what helps or makes it hard to use eptinezumab in real-world practice * To see if eptinezumab helps reduce migraine days and improve quality of life Data from interviews will be reviewed for common themes using special software. Outcome measures will be analyzed using standard statistical tools. The results of this study will help doctors and public health leaders understand how to make migraine treatment more accessible and effective for patients in Thailand.

Conditions

• Migraine
• Treatment
• Treatment Refusal

Interventions

Type	Name	Description
DRUG	Eptinezumab	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)
OTHER	Sham (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

Timeline

• Start date: 2025-08-25
• Primary completion: 2026-01-31
• Completion: 2026-03-31
• First posted: 2025-06-25
• Last updated: 2026-04-08

Locations

1 site across 1 country: Thailand