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NCT06001593
Pilot Study of Modulating Auditory Symptoms and Vertigo of Meniere's Disease by Non-invasive Mastoid Electric Stimulation: Double-blind, Randomized, Sham-controlled, Investigator-initiated Trial
Phase 1/Phase 2 trial testing YPS-201b in Meniere's Disease in 120 participants. Currently enrolling.
1 November 2025
Quick facts
| Lead sponsor | Seoul National University Hospital |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 18 September 2023 |
| Primary completion | 1 November 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- YPS-201b
- betahistine (BETAHISTINE) — full drug profile →
- YPS-201b
Conditions studied
- Meniere's Disease — all drugs for Meniere's Disease →
Sponsor
Seoul National University Hospital
Who can join
Adults 19 to 80, any sex, with Meniere's Disease. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Valuation of dizziness with Dizziness Visual Analogue scale(Efficacy)
Time frame: 0,2,4,8,12 weeks during electrical stimulation
Verifying therapeutic effect of electrical stimulation -
Evaluate vestibular-ocular reflex with Video head impulse test(Efficacy)
Time frame: 0,4,8,12 weeks during electrical stimulation
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. -
Valuation of hearing threshold with pure tone audiometry(Efficacy)
Time frame: 0,4,8,12 weeks during electrical stimulation
Verifying therapeutic effect of electrical stimulation.measuring the level of enhancement in low-frequency hearing. -
electroencephalography(Efficacy)
Time frame: 0,1,4,8,12 weeks during electrical stimulation
Verifying therapeutic effect of electrical stimulation,evaluate the inhibitory response of the brain through EEG readings following repeated stimulation.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06001593
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Meniere's Disease
Currently open trials in the same condition.
- NCT07518069 — Genetic and Biohumoral Factors Involved in Menière's Disease and Their Correlation With Phenotypes · recruiting
- NCT03587701 — Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Dise · Phase 2 · recruiting
Other Seoul National University Hospital trials
Trials by the same sponsor.
- NCT07262944 — EOI Block in Otoplasty With Rib Cartilage Graft · NA · recruiting
- NCT07464210 — Nemtabrutinib, Bortezomib, and Rituximab for WM · Phase 2 · not yet recruiting
- NCT07550803 — Effect of Intraoperative Dexamethasone on Early Postoperative Sleep Quality in Patients Undergoing Nasal Surgery · NA · not yet recruiting
- NCT07522138 — Home-based Self-exercise in Patients With Parkinson's Disease: A Feasibility Study · NA · not yet recruiting
- NCT07476651 — Scout Dose of Resin Microspheres · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06001593 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Seoul National University Hospital
- Last refreshed: 2 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06001593.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing