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MigraineFACEpiNCT07035197

Facilitators and Barriers to Eptinezumab Administration in Thailand

An observational study of Migraine and Treatment, run by Chulalongkorn University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Migraine, Treatment, Treatment Refusal
What is being tested?
Eptinezumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteThailand
Study dates
25 Aug 2025to 31 Mar 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study 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.

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 <!-- -->
  7. Age ≥ 18 years
  8. Diagnosed with migraine with or without aura or chronic migraine according to the ICHD-3*
  9. Have received eptinezumab infusion at the KCMH
  10. Have NEVER received any CGRP mAbs prior to starting eptinezumab
  11. Able to communicate in Thai fluently
  12. 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 <!-- -->
  5. Participants who cannot completely participate in an IDI, either in-person or online

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • King Chualongkorn Memorial Hospital, the Thai Red Cross Society

    Bangkok, 10330

Other trials in Thailand

About this study

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

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:

Read more
  • 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.

Read the 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.

Being tested
Eptinezumab, Sham (No Treatment)
Keywords
Migraine, CGRP, Eptinezumab, Mixed method, Real world, Thailand, Treatment, Barrier, Facilitator, Interview
Medical subject headings
Migraine Disorders, Treatment Refusal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EptinezumabDrug

    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
Study groups in NCT07035197
Study groupRoleWhat they receive
People with episodic or chronic migraine who have NEVER received CGRP mAb therapyPatients who were diagnosed migraine with or without aura or chronic migraine and have NEVER received eptinezumab. Inclusion 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 KCMH 4. Have NEVER received any CGRP mAbs prior to starting eptinezumab 5. Able to communicate in Thai fluently 6. Provide informed consent Exclusion 1. Participants who cannot completely participate in an in-depth interview 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
Receives: Drug: Eptinezumab
People with episodic or chronic migraine who have received CGRP mAb therapyPatients who were diagnosed migraine with or without aura or chronic migraine and have received eptinezumab. Inclusion 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 received other CGRP mAbs prior to starting eptinezumab 5. Able to communicate in Thai fluently 6. Provide informed consent Exclusion 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
Receives: Drug: Eptinezumab
Healthcare ProviderHealthcare providers (e.g. doctor, outpatient nurse and daycare nurse) who are responsible for providing eptinezumab to the patients. 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 1. Participants who cannot completely participate in an IDI, either in-person or online
Receives: Other: Sham (No Treatment)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Migraine patients' experiences after receiving eptinezumab

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

    1. Baseline visit at the time of enrollment.
    • A semi-structured IDI will be conducted within 24 hours of receiving eptinezumab.
    1. 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
    1. 6-month follow-up visit:
    • No interview

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

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

    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?

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

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

    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

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

Secondary outcomes (5)

  1. Changes in monthly migraine days (MMD)

    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.

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

  2. Changes in Migraine Disability Assessment (MIDAS) Score

    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

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

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

    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:
    1. Mobility
    2. Self-care
    3. Usual activities
    4. Pain/discomfort
    5. 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

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

  4. Changes in abortive medication use

    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

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

  5. Change in preventive medication use

    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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2025
  2. Study start25 Aug 2025
  3. Primary completion31 Jan 2026
  4. Study completion31 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07035197
Sponsor's protocol ID
Med Chula IRB 0329/68
Acronym
FACEpi
Status last verified
Jun 2025
First submitted
3 Jun 2025
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Argoff C, Herzog SP, Smith RM, Kotak SV, Sopina L, Saltarska Y, Soni-Brahmbhatt S, Khan FA. Real-world effectiveness and satisfaction with intravenous eptinezumab treatment in patients with chronic migraine: REVIEW, an observational, multi-site, US-based study. J Headache Pain. 2024 Apr 25;25(1):65. doi: 10.1186/s10194-024-01764-9.

    PubMed 38664605

  • Zhao YJ, Ong JJY, Sonu SK, Dang J, Ng CC, Herr KJ, Bose R, Jion YI. A real-world prospective observational study of eptinezumab in Asian patients with migraine. Headache. 2024 Jul-Aug;64(7):810-824. doi: 10.1111/head.14737. Epub 2024 May 24.

    PubMed 38785386

  • Winner PK, McAllister P, Chakhava G, Ailani J, Ettrup A, Krog Josiassen M, Lindsten A, Mehta L, Cady R. Effects of Intravenous Eptinezumab vs Placebo on Headache Pain and Most Bothersome Symptom When Initiated During a Migraine Attack: A Randomized Clinical Trial. JAMA. 2021 Jun 15;325(23):2348-2356. doi: 10.1001/jama.2021.7665.

    PubMed 34128999

Questions about this trial

What is this clinical trial studying?

An observational study of Migraine and Treatment, run by Chulalongkorn University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Migraine patients' experiences after receiving eptinezumab (time frame: At enrollment (witihin 24 hours of receiving eptinezumab) and 3 months follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07035197, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.

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