Facilitators and Barriers to Eptinezumab Administration in Thailand

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.

Conditions

• Migraine
• Treatment
• Treatment Refusal

Interventions

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

Sponsors & Collaborators

• H. Lundbeck A/S

  collaborator INDUSTRY

• Chulalongkorn University

  lead OTHER

Principal Investigators

• Prakit Anukoolwittaya, MD · Division of Neurology, Department of Medicine, King Chulalongkorn Memorial Hospital, The Thai Red Cross Society

• Thanakit Pongpitakmetha, MD, MSc · Department of Pharmacology, Faculty of Medicine, Chulalongkorn University

• Sekh Thanprasertsuk, MD · Department of Physiology, Faculty of Medicine, Chulalongkorn University

• Akarin Hiransuthikul, MD, MSc · Department of Preventive and Social Medicine, Faculty of Medicine, Chulalongkorn University

• Wanakorn Rattanawong, MD · Faculty of Medicine, King Mongkut's Institute of Technology Ladkrabang

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-08-25

Primary Completion

2026-01-31

Completion

2026-03-31

Countries

• Thailand

Study Locations