A Phase 1/2 interventional study of YPS-201b and betahistine in Meniere's Disease, sponsored by Seoul National University Hospital. Recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by Seoul National University Hospital · Phase 1/2, Interventional, and Treatment
This study is a Double-blind, Randomized, Sham-controlled, Investigator-initiated trial. To explore the effectiveness of non-invasive inner ear electrical stimulation of the mastoid behind the ear in controlling auditory symptoms and dizziness in patients with Meniere's disease.
74 studies on the registry are indexed under Meniere Disease; 12 are open to participants now.
This study's planned enrollment of 120 is above the median of 44 across 61 interventional studies indexed under Meniere Disease.
Browse Meniere Disease studies →Seoul National University Hospital is the lead sponsor of 1,900 studies on the registry; 274 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: YPS-201b · Drug: betahistine
Drug: betahistine · Device: YPS-201b
control group
Drug: betahistine
electrical stimulation device.
Relieve symptoms of balance disorders or dizziness
sham electrical stimulation device.
Valuation of dizziness with Dizziness Visual Analogue scale(Efficacy)
Verifying therapeutic effect of electrical stimulation
Time frame: 0,2,4,8,12 weeks during electrical stimulation
Evaluate vestibular-ocular reflex with Video head impulse test(Efficacy)
Verifying therapeutic effect of electrical stimulation,evaluate the function of the vestibulocochlear reflex in the semicircular canal and measure the extent of improvement in Meniere's disease.
Time frame: 0,4,8,12 weeks during electrical stimulation
Valuation of hearing threshold with pure tone audiometry(Efficacy)
Verifying therapeutic effect of electrical stimulation.measuring the level of enhancement in low-frequency hearing.
Time frame: 0,4,8,12 weeks during electrical stimulation
electroencephalography(Efficacy)
Verifying therapeutic effect of electrical stimulation,evaluate the inhibitory response of the brain through EEG readings following repeated stimulation.
Time frame: 0,1,4,8,12 weeks during electrical stimulation
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2023 (actual). Primary completion is estimated for Nov 2025, 26 months after the start.
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