Status:
COMPLETED
The Evaluation of the Transcutaneous Electrical Stimulation Medical Device's Safety and Effectiveness in Treating the Patients With Migraine
Lead Sponsor:
Nu Eyne Co., Ltd.
Conditions:
Migraine
Eligibility:
All Genders
19+ years
Phase:
NA
Brief 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 a...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
October 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05301920
Start Date
October 8 2021
End Date
January 28 2022
Last Update
December 14 2023
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea, 06351