Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT05301920
Eligibility Criteria:
Inclusion Criteria:
* Men and women over 19 years old
* Patients with migraine with or without migraine aura who meet ICHD-III (2018) diagnostic criteria 1.1 1.2
* Patients with history of migraine more than 1 year
* Patients who have headaches at least twice a month
* Those who do not take migraine prevention drugs from 12 weeks before screening to the end of the study, or who can maintain migraine prevention drugs during clinical trials without changing or adding additional migraine prevention drugs
* A person who voluntarily agreed to participate in this clinical trial
Exclusion Criteria:
* Those who are diagnosed with primary headaches (exception: low-frequency intermittent tension type headaches) and secondary headaches in addition to migraine headaches
* Those who are diagnosed with medication overuse headache in addition to migraine headaches
* Pregnant or lactating of women within 6months
* Among female subjects who are likely to be pregnant, those who disagree to contraception in a medically permitted manner during this clinical trial period. \*Medically permitted contraception: condom, Oral contraception that lasted for at least 3 months, contraceptive injection, contraceptive implant, intrauterine device, etc
* Patients with mental illness who can interfere with their participation in the study.
* In the case where medical devices for clinical trials cannot be applied due to being sensitive to orbital nerve stimulation.
* Patients with a history of drug or alcohol abuse
* Those who participated in other clinical trials within 30 days of screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT05301920
Study Brief:
Protocol Section:
NCT05301920