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COMPLETED

NCT07035197

Facilitators and Barriers to Eptinezumab Administration in Thailand

Sponsor: Chulalongkorn University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

Start Date

2025-08-25

Completion Date

2026-03-31

Last Updated

2026-04-08

Healthy Volunteers

Yes

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

Target Population * Group 1: Patients who were diagnosed migraine with or without aura or chronic migraine and have received eptinezumab. * Group 2: Healthcare providers (e.g. doctor, outpatient nurse and daycare nurse) who are responsible for providing eptinezumab to the patients. * Inclusion Criteria Group 1: People with migraine with or without aura or chronic migraine Inclusion criteria Group 1A 1. Age ≥ 18 years 2. Diagnosed with migraine with or without aura or chronic migraine according to the International Classification of Headache Disorders, 3rd edition (ICHD-3)\* 3. Have received eptinezumab infusion at the King Chulalongkorn Memorial Hospital (KCMH) 4. Have received other CGRP mAbs prior to starting eptinezumab 5. Able to communicate in Thai fluently 6. Provide informed consent Group 1B  1. Age ≥ 18 years 2. Diagnosed with migraine with or without aura or chronic migraine according to the ICHD-3\* 3. Have received eptinezumab infusion at the KCMH 4. Have NEVER received any CGRP mAbs prior to starting eptinezumab 5. Able to communicate in Thai fluently 6. Provide informed consent \* The diagnosis will be established by consensus between two headache specialists. In case of a discrepancy, conflicts will be resolved through a final consensus agreement between the two specialists prior to enrollment. Group 2: Healthcare providers Inclusion criteria  1. Age ≥ 18 years 2. Currently working at KCMH 3. Have been working at KCMH for more than 3 months 4. Involved in providing care to patients attending the Headache Clinic 5. Able to communicate in Thai fluently 6. Provide informed consent * Exclusion Criteria Group 1: People with migraine with or without aura or chronic migraine 1. Participants who cannot completely participate in an in-depth interview (IDI) and questionnaires, either in-person or online 2. Participants with headache disorders other than migraine with or without aura or chronic migraine 3. Alcohol or drug use that, in the opinion of the investigator, would interfere with completion of study procedures 4. A known history of allergy to eptinezumab Group 2: Healthcare providers  1. Participants who cannot completely participate in an IDI, either in-person or online

Locations (1)

King Chualongkorn Memorial Hospital, the Thai Red Cross Society

Bangkok, Thailand