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

NCT06170411 | Unknown

• 1 other identifier: NE_MIG_002
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of treating migraine in the acute phase by applying the acute mode (program 1) of Elexir (trigeminal nerve electrical stimulator) to patients with migraine.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• Changes in VAS score

  Check the change in VAS socre 1 hour after beginning of the TNS session. The VAS scale consists of a total of 11 points, and the higher the score, the greater the pain.

  1 hour after beginning of the TNS session.

Secondary Outcomes (9)

• Pain Freedom

  1 hour, 2 hours after beginning of the TNS session.

• Most Bothersome Migraine-associated Symptom Freedom

  1 hour, 2 hours after beginning of the TNS session.

• Pain Relief

  1 hour, 2 hours after beginning of the TNS session

• Percentage of Patients With Absence of Photophobia, Phonophobia, Nausea, Vomiting

  1 hour, 2 hours beginning of the TNS session

• Use of Rescue Medication Between 2 and 24 Hours

  2-24 hours after beginning of the TNS session

Study Arms (2)

Experimental Group

EXPERIMENTAL

1-hour trigeminal nerve stimulation with the Elexir (program1), as acute treatment of an early stage migraine attack

Device: Elexir (program1)

Control Group

SHAM COMPARATOR

1-hour trigeminal nerve stimulation with the sham device, as acute treatment of an early stage migraine attack

Device: sham device

Interventions

Elexir (program1) DEVICE

The Elexir is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as Trigeminal Nerve Stimulation. The Elexir will deliver trigeminal nerve stimulation.

Experimental Group

sham device DEVICE

The sham device will deliver sham trigeminal nerve stimulation.

Control Group

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women19 to 65
• 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.
• Having a history of migraine for more than 1 year
• Migraine onset before the age of 50
• Having between 2 and 8 migraine headaches\* per month for 2 months in each of the two months prior to screening
• 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

You may not qualify if:

• A person who has difficulty distinguishing between migraine and tension-type headache
• A person who suffer from headaches more than 15 days a month
• A person who underwents supraorbital nerve block within 4 months before the screening visit
• A person who received Botox treatment within 4 months before the screening visit
• Modification of a migraine prophylaxis treatment in the previous 3 months
• A person diagnosed with other primary headaches excluding tension-type headaches less than 4 times a month
• A person diagnosed with secondary headaches, including medication overuse headache
• History of drug or alcohol abuse
• 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)
• Pregnant or lactating women
• 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.
• A person who participated in another clinical trial within 30 days of the screening visit
• 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.)

Sponsors & Collaborators

• Nu Eyne Co., Ltd.: lead

Study Sites (2)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Uijeongbu Eulji Medical Center, Eulji University

Uijeongbu-si, South Korea

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Jinho Jung

CONTACT

+821083113509; jinho.jung@nueyne.com

Yongkun Lee

CONTACT

+821033798405; yongkun.lee@nueyne.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: December 14, 2023
• Study Start: October 27, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: December 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)