High-frequency EM or CM patients
Conditions
Interventions
Supplementing Standard Treatment with a Migraine Management App
Sponsors
Kawata Yumi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females aged 18 years or older and 65 years or younger at the time of consent acquisition 2. Patients with a history of migraine (according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) diagnostic criteria) at least 12 months prior to consent acquisition, or patients for whom migraine (not meeting criteria for any other disorder according to ICHD-3 diagnostic criteria) is suggested based on clinical judgment 3. Patients whose migraine onset occurred at age 50 or younger 4. Patients with high-frequency EM or CM who met the following criteria based on baseline information collected during the 28-day pre-observation period. A) For high-frequency EM: Monthly headache days were 8 or more but fewer than 15, and monthly migraine attack days were 8 or more. B) For chronic migraine (CM): Monthly headache days more than15 days and monthly migraine attack days more than 8 days. 5. Patients using one migraine preventive medication or none for migraine prevention or treatment of other conditions. However, if using migraine preventive medication, patients must not have started, changed*, or discontinued the medication within 2 months prior to consent acquisition. *Refers to changing the type of medication or altering the dosage regimen. 6. Patients who entered headache records into the recording app for 24 days or more during the 28-day pre-observation period (or 85% or more of the total days if the pre-observation period exceeds 28 days), and whose entries were deemed appropriate by the principal investigator or sub-investigator, confirming the patient's ability to enter data into the headache diary in a timely manner. 7. Patients from whom written informed consent for participation in the clinical trial can be obtained. 8. Patients possessing a smartphone or tablet device capable of running the investigational device (iOS 14.0 or later (18.0 or later recommended) or Android OS 7.0 or later (14.0 or later recommended)).
Exclusion criteria
Exclusion criteria: 1. Patients with 100% recorded instances of headache in the recording app during the pre-observation period 2. Patients who started, changed*, or discontinued migraine preventive medication within 2 months prior to consent acquisition, or who plan to start, change*, or discontinue such medication between consent acquisition and the end of the treatment period* (Change refers to altering the type of medication or its dosage/administration method) 3. Patients who received treatment with botulinum toxin or nerve block within 4 months prior to consent acquisition, or who planned to initiate such treatment between consent acquisition and the end of the treatment period. 4. Patients with a history of alcohol or substance abuse within the past 2 years, or a history of alcohol or substance dependence within the past 5 years. 5. Patients with secondary headaches, excluding those due to medication overuse. 6. Patients with pain syndromes (including trigeminal neuralgia), psychiatric disorders (major depressive disorder, bipolar disorder, schizophrenia, dementia, etc.), or other serious neurological disorders (excluding migraine) and psychiatric disorders that the principal investigator or sub-investigator considers will affect the evaluation of this trial (this does not apply if the principal investigator or sub-investigator considers that the presence of neurological or psychiatric disorders will not affect the evaluation of this trial) 7. Patients with a history of psychiatric disorders deemed clinically significant by the principal investigator or sub-investigator. 8. Patients who used migraine treatment devices (e.g., neuromodulation [magnetic stimulation, electrical stimulation]) or received acupuncture within 2 months prior to obtaining informed consent. 9. Patients clearly pregnant at the time of obtaining informed consent (does not include patients who may be pregnant, are breastfeeding, plan to become pregnant, or wish to become pregnant). 10. Patients who participated in any clinical trial within 4 weeks prior to consent acquisition 11. Patients who participated in the specific clinical research (trial number: jRCTs032220649) via the patient app 12. Patients with a family member living in the same household who is a participant in this trial 13. Other patients deemed ineligible by the principal investigator or sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in migraine days per 4 weeks from baseline to week 12 of treatment | — |
Contacts
Public ContactRio Hiruta
Hedgehog MedTech, Inc.
Outcome results
None listed