Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| H. Lundbeck A/S | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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:
Participants will:
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.
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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
Exclusion
|
| |
| 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
Exclusion
|
| |
| Healthcare Provider | Healthcare providers (e.g. doctor, outpatient nurse and daycare nurse) who are responsible for providing eptinezumab to the patients. Inclusion criteria
Exclusion criteria 1. Participants who cannot completely participate in an IDI, either in-person or online |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eptinezumab | Drug | Eptinezumab 100 mg IV q 3 months
|
| Measure | Description | Time Frame |
|---|---|---|
| Migraine patients' experiences after receiving eptinezumab | Group 1 (People with migraine with or without aura or chronic migraine):
| 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)
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At enrollment (witihin 24 hours of receiving eptinezumab), 3 months follow-up, and 6 months follow-up |
Not provided
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 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
Exclusion Criteria Group 1: People with migraine with or without aura or chronic migraine
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Chualongkorn Memorial Hospital, the Thai Red Cross Society | Bangkok | 10330 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38664605 | Background | 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. | |
| 38785386 |
| Label | URL |
|---|---|
| Thai version of the Migraine Disability Assessment Score (MIDAS) | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D016312 | Treatment Refusal |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000628361 | eptinezumab |
| C005703 | salicylhydroxamic acid |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Sham (No Treatment) | Other | ** No intervention, neither eptinezumab nor placebo, was given
|
|
| At enrollment (witihin 24 hours of giving eptinezumab administration) |
| 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:
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 |
| 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)) | 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:
Scoring
| At enrollment (witihin 24 hours of receiving eptinezumab), 3 months follow-up, and 6 months follow-up |
| 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
| At enrollment (witihin 24 hours of receiving eptinezumab), 3 months follow-up, and 6 months follow-up |
| 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
| At enrollment (witihin 24 hours of receiving eptinezumab), 3 months follow-up, and 6 months follow-up |
| 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. |
| 34128999 | 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. |
| D009422 | Nervous System Diseases |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |