Facilitators and Barriers to Eptinezumab Administration in Thailand

NCT07035197 | Completed

• 1 other identifier: Med Chula IRB 0329/68
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Migraine; CGRP; Eptinezumab; Mixed method; Real world; Thailand; Treatment; Barrier; Facilitator; Interview

Outcome Measures

Primary Outcomes (3)

• 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. 2. 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 3. 6-month follow-up visit: * No interview

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

• 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?

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

• 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

  At enrollment (witihin 24 hours of giving eptinezumab administration)

Secondary Outcomes (5)

• Changes in monthly migraine days (MMD)

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

• Changes in Migraine Disability Assessment (MIDAS) Score

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

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

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

• Changes in abortive medication use

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

• Change in preventive medication use

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

Study Arms (3)

People with episodic or chronic migraine who have NEVER received CGRP mAb therapy

Patients 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

Drug: Eptinezumab

People with episodic or chronic migraine who have received CGRP mAb therapy

Patients 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

Drug: Eptinezumab

Healthcare Provider

Healthcare 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

Other: Sham (No Treatment)

Interventions

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)

People with episodic or chronic migraine who have NEVER received CGRP mAb therapy; People with episodic or chronic migraine who have received CGRP mAb therapy

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

Healthcare Provider

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.
• <!-- -->

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead
• H. Lundbeck A/S: collaborator

Study Sites (1)

King Chualongkorn Memorial Hospital, the Thai Red Cross Society

Bangkok, 10330, Thailand

Location

Related Publications (3)

• 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.

  PMID: 38664605 BACKGROUND

• 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.

  PMID: 38785386 BACKGROUND

• 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.

  PMID: 34128999 BACKGROUND

Related Links

• Thai version of the Migraine Disability Assessment Score (MIDAS)

MeSH Terms

Conditions

Migraine Disorders; Treatment Refusal

Interventions

eptinezumab; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

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

Study Officials

• Prakit Anukoolwittaya, MD

  Division of Neurology, Department of Medicine, King Chulalongkorn Memorial Hospital, The Thai Red Cross Society

  PRINCIPAL INVESTIGATOR

• Thanakit Pongpitakmetha, MD, MSc

  Department of Pharmacology, Faculty of Medicine, Chulalongkorn University

  STUDY DIRECTOR

• Sekh Thanprasertsuk, MD

  Department of Physiology, Faculty of Medicine, Chulalongkorn University

  STUDY DIRECTOR

• Akarin Hiransuthikul, MD, MSc

  Department of Preventive and Social Medicine, Faculty of Medicine, Chulalongkorn University

  STUDY DIRECTOR

• Wanakorn Rattanawong, MD

  Faculty of Medicine, King Mongkut's Institute of Technology Ladkrabang

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 25, 2025
• Study Start: August 25, 2025
• Primary Completion: January 31, 2026
• Study Completion: March 31, 2026
• Last Updated: April 8, 2026

Record last verified: 2025-06

Locations

TH (1)