MigraineNCT06170411
Post-marketing Clinical Trial of Elexir(Trigeminal Nerve Electrical Stimulator) for the Acute Treatment of Migraine
A study testing Elexir (program1) in people with Migraine, run by Nu Eyne Co., Ltd. at 2 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Elexir (program1)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 27 Oct 2023to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.)
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Miji Lee, Ph. D., MD.
Miji Lee, Ph. D., MD.
- Recruiting
Uijeongbu Eulji Medical Center, Eulji University
Uijeongbu-si
Suhyun Cho, M.D., Ph.D.
Suhyun Cho, M.D., Ph.D.
About this study
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.
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.
Read the 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.
- Conditions
- Migraine
- Being tested
- Elexir (program1), sham device
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
sham deviceDevice
The sham device will deliver sham trigeminal nerve stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 1-hour trigeminal nerve stimulation with the Elexir (program1), as acute treatment of an early stage migraine attack Receives: 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 Receives: Device: sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour after beginning of the TNS session.
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 hour after beginning of the TNS session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start27 Oct 2023
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nu Eyne Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170411
- Sponsor's protocol ID
- NE_MIG_002
- Status last verified
- Nov 2023
- First submitted
- 8 Nov 2023
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06170411
- Acronym / sponsor ID
- NE_MIG_002
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nu Eyne Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Oct 2023 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: Elexir (program1)1-hour trigeminal nerve stimulation with the Elexir (program1), as acute treatment of an early stage migraine attack |
| Control Group | Sham comparator | Device: sham device1-hour trigeminal nerve stimulation with the sham device, as acute treatment of an early stage migraine attack |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Experimental Group |
| sham deviceThe sham device will deliver sham trigeminal nerve stimulation. | Device | Control Group |
Primary outcome
Changes in VAS score
Time frame: 1 hour after beginning of the TNS session.
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.
9 secondary outcomes
Pain Freedom
Time frame: 1 hour, 2 hours after beginning of the TNS session.
Most Bothersome Migraine-associated Symptom Freedom
Time frame: 1 hour, 2 hours after beginning of the TNS session.
Pain Relief
Time frame: 1 hour, 2 hours after beginning of the TNS session
Percentage of Patients With Absence of Photophobia, Phonophobia, Nausea, Vomiting
Time frame: 1 hour, 2 hours beginning of the TNS session
Use of Rescue Medication Between 2 and 24 Hours
Time frame: 2-24 hours after beginning of the TNS session
Sustained Pain Freedom at 24 Hours
Time frame: 24 hours after beginning of the TNS session
Sustained Pain Relief at 24 Hours
Time frame: 24 hours after beginning of the TNS session
Changes in headache intensity
Time frame: 1 hour, 2 hours, 24 hours after beginning of the TNS session
Rate of change in VAS score
Time frame: 1 hour after beginning of the TNS session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elexir (program1) in people with Migraine, run by Nu Eyne Co., Ltd. at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinho Jung (+821083113509, jinho.jung@nueyne.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in VAS score (time frame: 1 hour after beginning of the TNS session.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023.