Skip to main content
OpenTrials
Completed

NCT Number: NCT07035197

Facilitators and Barriers to Eptinezumab Administration in Thailand

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Migraine Behavior Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Health Behavior Migraine Disorders Nervous System Diseases Treatment Treatment Adherence and Compliance Treatment Refusal

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

King Chualongkorn Memorial Hospital, the Thai Red Cross Society

Bangkok, 10330, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • Age ≥ 18 years
  • Diagnosed with migraine with or without aura or chronic migraine according to the International Classification of Headache Disorders, 3rd edition (ICHD-3)*
  • Have received eptinezumab infusion at the King Chulalongkorn Memorial Hospital (KCMH)
  • Have received other CGRP mAbs prior to starting eptinezumab
  • Able to communicate in Thai fluently
  • Provide informed consent Group 1B

<!-- -->

  • Age ≥ 18 years
  • Diagnosed with migraine with or without aura or chronic migraine according to the ICHD-3*
  • Have received eptinezumab infusion at the KCMH
  • Have NEVER received any CGRP mAbs prior to starting eptinezumab
  • Able to communicate in Thai fluently
  • 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

<!-- -->

  • Age ≥ 18 years
  • Currently working at KCMH
  • Have been working at KCMH for more than 3 months
  • Involved in providing care to patients attending the Headache Clinic
  • Able to communicate in Thai fluently
  • Provide informed consent
  • Exclusion Criteria Group 1: People with migraine with or without aura or chronic migraine
  • Participants who cannot completely participate in an in-depth interview (IDI) and questionnaires, either in-person or online
  • Participants with headache disorders other than migraine with or without aura or chronic migraine
  • Alcohol or drug use that, in the opinion of the investigator, would interfere with completion of study procedures
  • A known history of allergy to eptinezumab Group 2: Healthcare providers

<!-- -->

  • Participants who cannot completely participate in an IDI, either in-person or online

Treatment and study plan

Eptinezumab

Drug

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)

Sham (No Treatment)

Other

** 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

Primary outcomes

  1. Migraine patients' experiences after receiving eptinezumab

    Time frame: At enrollment (witihin 24 hours of receiving eptinezumab) and 3 months follow-up

    Group 1 (People with migraine with or without aura or chronic migraine):

    • Baseline visit at the time of enrollment.
    • A semi-structured IDI will be conducted within 24 hours of receiving eptinezumab.
    • 3-month follow-up visit:
    • Participants will complete a set of questionnaires to assess their experiences after receiving eptinezumab infusion
    • A brief semi-structure interview
    • 6-month follow-up visit:
    • No interview

  2. Facilitators and barriers of integrating the use of eptinezumab in the headache specialty clinic in Thailand from the perspective of migraine patients

    Time frame: At enrollment (witihin 24 hours of receiving eptinezumab) and 3 months follow-up

    Group 1 (People with migraine with or without aura or chronic migraine)

    • Baseline visit: Within 24 hours of receiving eptinezumab
    • Semi-structured IDI (duration of IDI ~30 - 45 minutes)
    • Satisfactory, acceptance, adaptability, feasibility, cost of eptinezumab administration
    • Patients' migraine symptoms and their impact on daily life, emotional well-being, and social well-being.
    • The perspective of oral and non-oral form of prevention medicine
    • Patients' experiences of migraine symptom improvement and the wearing-off effect during prior anti-CGRP injections in the group with previously failed anti-CGRP treatments.
    • Patients' migraine symptoms between administration of eptinezumab
    • 3-month follow-up visits (duration of interview: ~10 minutes)
    • Brief interview (duration of interview: ~10 minutes)
    • What are your thoughts on eptinezumab infusion?
    • What is the difference between prior anti-CGRP treatments and eptinezumab in prior anti CGRP group?

  3. Facilitators and barriers of integrating the use of eptinezumab in the headache specialty clinic in Thailand from the perspective of healthcare providers

    Time frame: At enrollment (witihin 24 hours of giving eptinezumab administration)

    Group 2 (Healthcare providers) o Baseline visits: Within 24 hours of giving eptinezumab administration (duration of IDI ~30 - 45 minutes)

    • Semi-structured IDI exploring facilitators and barriers of integrating the use of eptinezumab in the headache specialty clinic in Thailand

Secondary outcomes

  1. Changes in monthly migraine days (MMD)

    Time frame: At enrollment (witihin 24 hours of receiving eptinezumab), 3 months follow-up, and 6 months follow-up

    Group 1 (People with migraine with or without aura or chronic migraine)

    Monthly migraine days are measured by patient self-report or headache diary review by investigators.

  2. Changes in Migraine Disability Assessment (MIDAS) Score

    Time frame: At enrollment (witihin 24 hours of receiving eptinezumab), 3 months follow-up, and 6 months follow-up

    The MIDAS score is a validated questionnaire used to quantify migraine-related disability over the past 3 months. It consists of five main items assessing the number of days of activity limitation due to migraine in three domains: work/school, household chores, and social/leisure activities.

    Scoring The total MIDAS score (Minimum value: 0 Maximum value: 270 Higher scores mean a worse disability) is calculated by summing responses to the five main items (each answered as the number of days affected).

    Disability Severity Grading:

    • Grade I (0-5): Little or no disability
    • Grade II (6-10): Mild disability
    • Grade III (11-20): Moderate disability
    • Grade IV (21+): Severe disability

    Two additional questions assess number of headache days per 3 months and average headache pain intensity (on a scale of 0-10), but these do not contribute to the total score.

    Thai MIDAS version was applied and administered by trained investigators https://doi.org/10.31524/bkkmedj.2018.02.003

  3. Changes in Quality of Life (EuroQoL (EQ-5D-3L))

    Time frame: At enrollment (witihin 24 hours of receiving eptinezumab), 3 months follow-up, and 6 months follow-up

    Quality of life as measured by the Thai version of the EQ-5D-5L questionnaire. The raw scores were transformed to utility scores for Thai population as previously suggested (Pattanaphesaj J., 2018).

    Structure The EQ-5D-3L includes:

    • Five dimensions:
    • Mobility
    • Self-care
    • Usual activities
    • Pain/discomfort
    • Anxiety/depression Each dimension has three levels:
    • No problems (Level 1)
    • Some problems (Level 2)
    • Extreme problems (Level 3) The combination of levels across dimensions defines a unique health state (e.g., 11223). A total of 243 health states are possible.

    Scoring

    • Each health state is converted into a single index value (utility score) using a Thai-specific value set.
    • Utility scores typically range from -0.452 to 1.000, where:
    • 1.000 = full health
    • 0 = death
    • <0 = states perceived worse than death

  4. Changes in abortive medication use

    Time frame: At enrollment (witihin 24 hours of receiving eptinezumab), 3 months follow-up, and 6 months follow-up

    Abortive medication use is reviewed by patient self-report and rechecked with the electronic medical record information by investigators

    Data collection

    • Generic name
    • Dosage (mg)
    • Number of pills used per month

  5. Change in preventive medication use

    Time frame: At enrollment (witihin 24 hours of receiving eptinezumab), 3 months follow-up, and 6 months follow-up

    Preventive medication use is reviewed by patient self-report and rechecked with the electronic medical record information by investigators

    Data collection

    • Generic name
    • Dosage (mg)
    • Number of pills used per month

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Collaborators

  • H. Lundbeck A/S

Registry information

Official study title

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

Acronym: FACEpi

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 25, 2025
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.