MigraineNCT05301920
The Evaluation of the Transcutaneous Electrical Stimulation Medical Device's Safety and Effectiveness in Treating the Patients With Migraine
A study testing Elexir (trigeminal nerve electrical stimulator) in people with Migraine, run by Nu Eyne Co., Ltd. at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the safety and effectiveness of trigeminal nerve electrical stimulator on reducing the frequency of migraine onset. It is applied to migraine patients and analyzes the results by comparing them before and after 4weeks. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- Elexir (trigeminal nerve electrical stimulator)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Oct 2021to 28 Jan 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women over 19 years old
- Patients with migraine with or without migraine aura who meet ICHD-III (2018) diagnostic criteria 1.1 1.2
- Patients with history of migraine more than 1 year
- Patients who have headaches at least twice a month
- Those who do not take migraine prevention drugs from 12 weeks before screening to the end of the study, or who can maintain migraine prevention drugs during clinical trials without changing or adding additional migraine prevention drugs
- A person who voluntarily agreed to participate in this clinical trial
Who cannot join
- Those who are diagnosed with primary headaches (exception: low-frequency intermittent tension type headaches) and secondary headaches in addition to migraine headaches
- Those who are diagnosed with medication overuse headache in addition to migraine headaches
- Pregnant or lactating of women within 6months
- Among female subjects who are likely to be pregnant, those who disagree to contraception in a medically permitted manner during this clinical trial period. *Medically permitted contraception: condom, Oral contraception that lasted for at least 3 months, contraceptive injection, contraceptive implant, intrauterine device, etc
- Patients with mental illness who can interfere with their participation in the study.
- In the case where medical devices for clinical trials cannot be applied due to being sensitive to orbital nerve stimulation.
- Patients with a history of drug or alcohol abuse
- Those who participated in other clinical trials within 30 days of screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Open-label, Clinical Effect Observational Study to Evaluate the Safety and Effectiveness of Reducing the Frequency of Migraine Onset Through Clinical Application of Elexir (Trigeminal Nerve Electrical Stimulator) in Migraine Patients
The purpose of this study is to investigate the safety and effectiveness of trigeminal nerve electrical stimulator on reducing the frequency of migraine onset. It is applied to migraine patients and analyzes the results by comparing them before and after 4weeks.
Read the detailed description
- Duration of study period (per participant): Screening period (-6~0weeks), Intervention period (4weeks).
- Patient needs to visit site at least 3 times (Screening, Baseline, V4), V2 can be done with screening visit. V3 is tele-Visit.
- The clinical trial device performs a personal electrical stimulation around the trigeminal nerves for 4weeks (6 times/week), 20 minutes each time.
- During the study period, examination and treatment methods are carried out in the same way.
- Conditions
- Migraine
- Being tested
- Elexir (trigeminal nerve electrical stimulator)
- 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 (trigeminal nerve electrical stimulator)Device
Elexir performs a personal electrical stimulation around the trigeminal nerves for 4weeks (6 times/week), 20 minutes each time.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | N=20 60Hz pulse electrical stimulation The clinical trial device performs a personal electrical stimulation around the trigeminal nerves for 4weeks (6 times/week), 20 minutes each time. Receives: Device: Elexir (trigeminal nerve electrical stimulator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of days of moderate to severe headache
Check the number of days of moderate to severe headache at 4 weeks after start compared to baseline
Measured: baseline, 4 weeks
Secondary outcomes (6)
Change in the number of headache days
Check the number of headache days in 4 weeks after the start of stimulation compared to the baseline
Measured: baseline, 4 weeks
Change in the frequency of headache days
Check the frequency of headache days in 4 weeks after the start of stimulation compared to the baseline
Measured: baseline, 4 weeks
Change in the frequency of taking the acute phase drug
Check the frequency of taking the acute phase drug in 4 weeks after the start of stimulation compared to the baseline
Measured: baseline, 4 weeks
Change in pain intensity when headache occurs
Check the change in pain intensity when headache occurs in 4 weeks after the start of stimulation compared to the baseline
Measured: baseline, 4 weeks
Change in the headache effect assessment (HIT-6) score
Check the change in the headache effect assessment (HIT-6) in 4 weeks after the start of stimulation compared to the baseline
Measured: baseline, 4 weeks
Change in the migraine-related quality of life (MSQ 2.1) score
Check the migraine-related quality of life (MSQ 2.1) change in 4 weeks after the start of stimulation compared to the baseline
MSQ 2.1 measures the impact of migraine across three essential aspects. The MSQ total and scale score varies between 0 and 100 with higher scores indicating higher impact.
Measured: baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start8 Oct 2021
- Primary completion28 Jan 2022
- Study completion28 Jan 2022
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
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
- NCT05301920
- Sponsor's protocol ID
- NE_MIG_001
- Status last verified
- Dec 2023
- First submitted
- 21 Mar 2022
- Last updated
- 14 Dec 2023
- Results posted
- 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 Single-center, Open-label, Clinical Effect Observational Study to Evaluate the Safety and Effectiveness of Reducing the Frequency of Migraine Onset Through Clinical Application of Elexir (Trigeminal Nerve Electrical Stimulator) in Migraine Patients
- ClinicalTrials.gov ID
- NCT05301920
- Acronym / sponsor ID
- NE_MIG_001
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nu Eyne Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Oct 2021 (actual)
- Primary completion
- 28 Jan 2022 (actual)
- Study completion
- 28 Jan 2022 (actual)
- First posted
- 31 Mar 2022 (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 investigate the safety and effectiveness of trigeminal nerve electrical stimulator on reducing the frequency of migraine onset. It is applied to migraine patients and analyzes the results by comparing them before and after 4weeks.
Detailed description
- Duration of study period (per participant): Screening period (-6~0weeks), Intervention period (4weeks).
- Patient needs to visit site at least 3 times (Screening, Baseline, V4), V2 can be done with screening visit. V3 is tele-Visit.
- The clinical trial device performs a personal electrical stimulation around the trigeminal nerves for 4weeks (6 times/week), 20 minutes each time.
- During the study period, examination and treatment methods are carried out in the same way.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: Elexir (trigeminal nerve electrical stimulator)N=20 60Hz pulse electrical stimulation The clinical trial device performs a personal electrical stimulation around the trigeminal nerves for 4weeks (6 times/week), 20 minutes each time. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women over 19 years old
- Patients with migraine with or without migraine aura who meet ICHD-III (2018) diagnostic criteria 1.1 1.2
- Patients with history of migraine more than 1 year
- Patients who have headaches at least twice a month
- Those who do not take migraine prevention drugs from 12 weeks before screening to the end of the study, or who can maintain migraine prevention drugs during clinical trials without changing or adding additional migraine prevention drugs
Key exclusion criteria (8 listed)
- Those who are diagnosed with primary headaches (exception: low-frequency intermittent tension type headaches) and secondary headaches in addition to migraine headaches
- Those who are diagnosed with medication overuse headache in addition to migraine headaches
- Pregnant or lactating of women within 6months
- Among female subjects who are likely to be pregnant, those who disagree to contraception in a medically permitted manner during this clinical trial period. *Medically permitted contraception: condom, Oral contraception that lasted for at least 3 months, contraceptive injection, contraceptive implant, intrauterine device, etc
- Patients with mental illness who can interfere with their participation in the study.
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 (trigeminal nerve electrical stimulator)Elexir performs a personal electrical stimulation around the trigeminal nerves for 4weeks (6 times/week), 20 minutes each time. | Device | Experimental Group |
Primary outcome
Change in the number of days of moderate to severe headache
Time frame: baseline, 4 weeks
Check the number of days of moderate to severe headache at 4 weeks after start compared to baseline
6 secondary outcomes
Change in the number of headache days
Time frame: baseline, 4 weeks
Change in the frequency of headache days
Time frame: baseline, 4 weeks
Change in the frequency of taking the acute phase drug
Time frame: baseline, 4 weeks
Change in pain intensity when headache occurs
Time frame: baseline, 4 weeks
Change in the headache effect assessment (HIT-6) score
Time frame: baseline, 4 weeks
Change in the migraine-related quality of life (MSQ 2.1) score
Time frame: baseline, 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elexir (trigeminal nerve electrical stimulator) in people with Migraine, run by Nu Eyne Co., Ltd. at 1 site 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 6 inclusion and 8 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: finished, 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 1 site 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the number of days of moderate to severe headache (time frame: baseline, 4 weeks). 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.