Post-marketing Clinical Trial of Elexir(Trigeminal Nerve Electrical Stimulator) for the Acute Treatment of Migraine

Exclusion Criteria

• •1. A person who has difficulty distinguishing between migraine and tension-type headache
• •2. A person who suffer from headaches more than 15 days a month
• •3. A person who underwents supraorbital nerve block within 4 months before the screening visit
• •4. A person who received Botox treatment within 4 months before the screening visit
• •5. Modification of a migraine prophylaxis treatment in the previous 3 months
• •6. A person diagnosed with other primary headaches excluding tension-type headaches less than 4 times a month
• •7. A person diagnosed with secondary headaches, including medication overuse headache
• •8. History of drug or alcohol abuse
• •9. A person judged to have other reasons for prohibiting the use of medical devices for clinical trials: A person implanted with metal or electronic devices such as head and neck implants, including deep brain stimulation devices, and persons implanted with implantable and wearable pacemakers. Those included in product precautions and contraindications (not applicable to dental implants)
• •10. Pregnant or lactating women
• •11. Among female subjects with childbearing potential, those who do not agree to maintain abstinence(not having sexual intercourse with the opposite sex) or to use contraception using a medically acceptable method\* during the period of this clinical trial
• •\*Medically acceptable contraceptive methods: condoms, oral contraception for at least 3 months, use of injectable or insertable contraceptives, installation of an intrauterine contraceptive device, etc.
• •12. A person who participated in another clinical trial within 30 days of the screening visit
• •13. In other cases where the researcher determines that participation in the study is difficult (If you do not understand or cannot read the consent form for this clinical trial, etc.)