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

Migraine Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06170411
• Other study ID #: NE_MIG_002
• Status: Recruiting
• Phase: N/A
• Start date: October 27, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: November 2023
• Source: Nu Eyne Co., Ltd.
• Contact: Jinho Jung
• Phone: +821083113509
• Email: jinho.jung[@]nueyne.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

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 device
The sham device will deliver sham trigeminal nerve stimulation.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Uijeongbu Eulji Medical Center, Eulji University	Uijeongbu

Sponsors (1)

Lead Sponsor	Collaborator
Nu Eyne Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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