Using Elexir to treat acute migraine attacks
A Multicenter, Double-blind, Parallel Design, Randomized, Placebo Controlled, Post-marketing Clinical Trial to Evaluate the Efficacy and Safety of Elexir (Trigeminal Nerve Electrical Stimulator) in Migraine Patients.
This study is testing whether the Elexir device, which stimulates a nerve in the head, can help people with acute migraine attacks feel better compared to a fake device.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 19 Years to 65 Years |
| Sex | All |
| Sponsor | Nu Eyne Co., Ltd. Industry-sponsored |
| Locations | 2 sites (Seoul and 1 other locations) |
| Trial ID | NCT06170411 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of the Elexir device, which stimulates the trigeminal nerve, for treating acute migraine attacks. Participants will be randomly assigned to either the Elexir device or a sham device and will use it at home during migraine episodes. They will maintain a migraine diary to track their symptoms and treatment response over an 8-week period. Follow-up visits will occur to assess device usage and migraine outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 to 65 who experience 2 to 8 migraine attacks per month and meet specific migraine criteria.
Not a fit: Patients with difficulty distinguishing between migraine and tension-type headaches or those with certain types of migraines may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-pharmacological option for patients suffering from acute migraines.
How similar studies have performed: Other studies using nerve stimulation for migraine treatment have shown promise, suggesting potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Men and women19 to 65
2. A person who meet the ICHD-III (2018) criteria for migraine without aura and migraine with aura (ICHD-III sections 1.1, 1.2) However, typical aura, migraine with brainstem aura, and hemiplegic migraine without headache are excluded.
3. Having a history of migraine for more than 1 year
4. Migraine onset before the age of 50
5. Having between 2 and 8 migraine headaches\* per month for 2 months in each of the two months prior to screening
6. A person who voluntarily agreed in writing to participate in this clinical trial
* Migraine headache: Migraine attack lasting 4 to 72 hours (if untreated or inadequately treated), unilateral pulsating pattern, moderate or severe pain intensity (Grade 2 or 3 on the four-point Likert Scale), nausea, and /or headache accompanied by photophobia and phonophobia
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.)
Where this trial is running
Seoul and 1 other locations
- Seoul National University Hospital — Seoul, Korea, Republic of (Recruiting)
- Uijeongbu Eulji Medical Center, Eulji University — Uijeongbu, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Jinho Jung
- Email: jinho.jung@nueyne.com
- Phone: +821083113509
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.