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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Migraine
• Intervention / Treatment: Device: Elexir (program1); Device: sham device

Detailed Description

Written consent is obtained from the subjects before proceeding with this study. Afterwards, the selection/exclusion criteria are checked to determine whether they are suitable for participation in the study. Subjects who meet the final selection/exclusion criteria are randomly assigned and assigned to the test group or control group in a 1:1 ratio, clinical research coordinator will provide the subject with Investigational device to use at home and migraine diary, AE reporting form If migraine occurs within 8 weeks at home, the subject applies a investigational device (test device or control device) for 1 hour. A migraine diary is written after a migraine occurs and before starting a investigational device.

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jinho Jung; Phone Number: +821083113509; Email: jinho.jung@nueyne.com
• Study Contact Backup: Name: Yongkun Lee; Phone Number: +821033798405; Email: yongkun.lee@nueyne.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Contact: Miji Lee, Ph. D., MD.
    • Principal Investigator: Miji Lee, Ph. D., MD.
  • Uijeongbu, Korea, Republic of
    • Recruiting
    • Uijeongbu Eulji Medical Center, Eulji University
    • Contact: Suhyun Cho, M.D., Ph.D.
    • Principal Investigator: Suhyun Cho, M.D., Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; 1-hour trigeminal nerve stimulation with the Elexir (program1), as acute treatment of an early stage migraine attack	Device: 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 Comparator: Control Group; 1-hour trigeminal nerve stimulation with the sham device, as acute treatment of an early stage migraine attack	Device: sham device; The sham device will deliver sham trigeminal nerve stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Freedom	The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to no headache (Grade 0) at 1hour, 2 hours after beginning of the TNS session.	1 hour, 2 hours after beginning of the TNS session.
Most Bothersome Migraine-associated Symptom Freedom	The percentage of patients with absence, at 1 hour, 2 hours after the beginning of the TNS session, of the most bothersome migraine-associated symptom identified at baseline.	1 hour, 2 hours after beginning of the TNS session.
Pain Relief	The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to a mild headache or to no headache (Grade 1 or 0) at 1 hour, 2 hours after beginning of the TNS session.	1 hour, 2 hours after beginning of the TNS session
Percentage of Patients With Absence of Photophobia, Phonophobia, Nausea, Vomiting	The percentage of patients with absence of photophobia, phonophobia, nausea, vomiting at 1 hour, 2 hours after beginning of the TNS session.	1 hour, 2 hours beginning of the TNS session
Use of Rescue Medication Between 2 and 24 Hours	The percentage of patients who took anti-migraine rescue medication between 2 and 24 hours after beginning of the TNS session.	2-24 hours after beginning of the TNS session
Sustained Pain Freedom at 24 Hours	The percentage of patients having no headache (Grade 0) at 2 hours, with no use of anti-migraine rescue medication and no relapse of headache pain within the 24 hours after the beginning of the TNS session.	24 hours after beginning of the TNS session
Sustained Pain Relief at 24 Hours	The percentage of patients having mild or no headache (Grade 1 or 0) at 2 hours, with no use of anti-migraine rescue medication and no relapse of headache pain within the 24 hours after the beginning of the TNS session.	24 hours after beginning of the TNS session
Changes in headache intensity	Check the change in Likert Scale 1 hour, 2 hours, 24 hours after beginning of the TNS session.	1 hour, 2 hours, 24 hours after beginning of the TNS session
Rate of change in VAS score	Check the rate of change in VAS socre 1 hour after beginning of the TNS session.	1 hour after beginning of the TNS session

Collaborators and Investigators

• Sponsor: Nu Eyne Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Actual): December 14, 2023

Study Record Updates

• Last Update Posted (Actual): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: NE_MIG_002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No