Post-marketing Clinical Trial of Elexir(Trigeminal Nerve Electrical Stimulator) for the Acute Treatment of Migraine
NCT ID: NCT06170411
Last Updated: 2023-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2023-10-27
2024-08-01
Brief Summary
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Detailed Description
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A migraine diary is written 1 and 2 hours after the start of application of the investigational device, and acute migraine treatment medications can be taken from that point on. Then, the subject writes migraine diary again 24 hours after starting to apply the investigational device.
Subjects who have applied the investigational device must visit the institution within 7 days after application and return the investigational device and the migraine headache.
If a subject does not occure a migraine within an 8-week period, subject must visit the institution and return the investigational device and migraine diary.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Experimental Group
1-hour trigeminal nerve stimulation with the Elexir (program1), as acute treatment of an early stage migraine attack
Elexir (program1)
The Elexir is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as Trigeminal Nerve Stimulation. The Elexir will deliver trigeminal nerve stimulation.
Control Group
1-hour trigeminal nerve stimulation with the sham device, as acute treatment of an early stage migraine attack
sham device
The sham device will deliver sham trigeminal nerve stimulation.
Interventions
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Elexir (program1)
The Elexir is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as Trigeminal Nerve Stimulation. The Elexir will deliver trigeminal nerve stimulation.
sham device
The sham device will deliver sham trigeminal nerve stimulation.
Eligibility Criteria
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Inclusion Criteria
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
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.)
19 Years
65 Years
ALL
No
Sponsors
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Nu Eyne Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Seoul National University Hospital
Seoul, , South Korea
Uijeongbu Eulji Medical Center, Eulji University
Uijeongbu-si, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Miji Lee, Ph. D., MD.
Role: primary
Suhyun Cho, M.D., Ph.D.
Role: primary
Other Identifiers
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NE_MIG_002
Identifier Type: -
Identifier Source: org_study_id