Source: ClinicalTrials.gov — U.S. National Library of Medicine — A database of privately and publicly funded clinical studies conducted around the world (U.S. National Library of Medicine, public domain).
This page lists clinical trials related to Meniere’s Disease from the ClinicalTrials.gov database.
Trial Summary
- Total studies: 50
- Recruiting: 8
- Active, not recruiting: 2
- Completed: 24
- Other: 16
Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.
Recruiting Trials
NCT03587701 — Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere’s Disease and Autoimmune Inner Ear Disease
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Northwell Health |
| Enrollment | 57 |
| Study Type | INTERVENTIONAL |
| Conditions | Autoimmune Inner Ear Disease; Meniere’s Disease |
| Interventions | ; ; |
A Phase II randomized, placebo controlled study design of anakinra (Kineret) in corticosteroid-resistant or intolerant Meniere’s disease (CR-MD)and corticosteroid-resistant or intolerant autoimmune inner ear disease (CR-AIED) patients. Patients will be randomized by a 2:1 allocation to anakinra or placebo for 42 continuous days. After day 42, a second placebo-controlled period will begin for an…
NCT04806282 — Deep Phenotyping of Hearing Instability Disorders: Cohort Establishment, Biomarker Identification, Development of Novel Phenotyping Measures, and Discovery of Therapeutic Targets
| Status | Recruiting |
| Phase | N/A |
| Sponsor | National Institute on Deafness and Other Communication Disorders (NIDCD) |
| Enrollment | 210 |
| Study Type | OBSERVATIONAL |
| Conditions | Meniere’s Disease; Enlarged Vestibular Aqueduct Syndrome; Autoimmune Inner Ear Disease |
Background:
Disorders of hearing instability (HI) are poorly characterized and ineffectively treated. HI can cause fluctuations in hearing thresholds and speech understanding. Researchers want to use a specialized form of magnetic resonance imaging (MRI) and blood tests to learn more about HI.
Objective:
To characterize a cohort of people with HI and to correlate HI with other data, includin…
NCT05582837 — Treatment of Meniere’s Disease With Migraine Medications
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of California, Irvine |
| Enrollment | 40 |
| Study Type | INTERVENTIONAL |
| Conditions | Ménière |
| Interventions |
Meniere’s disease (MD) is a chronic disease with a variety of fluctuating signs and symptoms, which include vertigo, hearing loss, tinnitus (ringing noise in the ear), aural pressure (feeling of ear fullness), and disequilibrium (lack of stability). Vertigo represents one of the most common and distressing problems in MD patients, and it causes various somatic and psychological disorders that i…
NCT06001593 — Modulating Auditory Symptoms and Vertigo of Meniere’s Disease by Non-invasive Mastoid Electric Stimulation
| Status | Recruiting |
| Phase | Phase 1 / Phase 2 |
| Sponsor | Seoul National University Hospital |
| Enrollment | 120 |
| Study Type | INTERVENTIONAL |
| Conditions | Meniere’s Disease |
| Interventions | ; ; |
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.
NCT05851508 — The Effecttiveness of Intratympanic Methylprednisolon Injections Compared to Placebo in the Treatment of Vertigo Attacks in Meniere’s Disease
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Leiden University Medical Center |
| Enrollment | 148 |
| Study Type | INTERVENTIONAL |
| Conditions | Meniere Disease |
| Interventions | ; |
Ménière’s disease is an inner ear disorder in which patients suffer from attacks of vertigo, tinnitus and hearing loss. To date, it is unclear what the best treatment for this condition is. Giving injections in the inner ear with the adrenal cortical hormone methylprednisolone is a treatment that is already widely used, but still there is insufficient evidence in the effectiveness of this treat…
NCT07518069 — Genetic and Biohumoral Factors Involved in Menière’s Disease and Their Correlation With Phenotypes
| Status | Recruiting |
| Phase | N/A |
| Sponsor | IRCCS San Raffaele |
| Enrollment | 250 |
| Study Type | OBSERVATIONAL |
| Conditions | Vertigo; Meniere’s Disease; Vestibular Migraine |
| Interventions | ; |
Aim of this work was to assess the role of polymorphisms belonging to genes involved in the regulation of ionic homeostasis in Caucasian patients with Ménière Disease (MD) and compare results with a cohort of patients affected by vestibular migraine and a cohort of non vestibular subjects
NCT07272473 — Effects of Cervical Mobilization on Dizziness, Balance, and Joint Position Sense in Patients With Meniere’s Disease
| Status | Recruiting |
| Phase | N/A |
| Sponsor | Abant Izzet Baysal University |
| Enrollment | 33 |
| Study Type | INTERVENTIONAL |
| Conditions | Meniere Disease |
| Interventions | ; |
The study will employ a stratified randomization method. Patients presenting to the Afyonkarahisar Health Sciences University Health Application and Research Center, Ear, Nose, and Throat Outpatient Clinic, with a definitive diagnosis of Meniere’s disease, unilateral or bilateral involvement, and who consent to participate in the study will be divided into three groups. The control group will r…
NCT06859788 — SPI-1005 for the Treatment of Meniere’s Disease (Open Label)
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Sound Pharmaceuticals, Incorporated |
| Enrollment | 200 |
| Study Type | INTERVENTIONAL |
| Conditions | Meniere’s Disease; Ménière’s Disease |
| Interventions |
Study of the safety of open-label SPI-1005 400 mg BID treatment in adults with Meniere’s Disease (MD) for 6 or 12 months to support chronic or chronic intermittent use.
Active, Not Recruiting
NCT03795675 — CI Following VS Removal or Labyrinthectomy
| Status | Active, not recruiting |
| Phase | N/A |
| Sponsor | Ohio State University |
| Enrollment | 15 |
| Study Type | INTERVENTIONAL |
| Conditions | Vestibular Schwannoma; Meniere Disease |
| Interventions |
This study is a prospective, clinical study to determine if it is safe and effective to use a cochlear implant over time in individuals undergoing removal of a vestibular schwannoma (VS), benign tumor of the hearing and balance nerve or undergoing a labyrinthectomy for treatment of Meniere’s disease. Individuals undergoing these surgeries will be deaf on the surgical side after the procedure. C…
NCT04815187 — Repurposed Use of Allergic Rhinitis and Allergic Asthma Drug to Reduce Vertigo and Hearing Loss in Meniere’s Disease
| Status | Active, not recruiting |
| Phase | Phase 4 |
| Sponsor | House Ear Institute |
| Enrollment | 39 |
| Study Type | INTERVENTIONAL |
| Conditions | Meniere Disease; Allergic Rhinitis; Vertigo |
| Interventions | ; |
The purpose of this study is to evaluate a previously FDA-approved medication that is known to help with allergy symptoms to see if it can decrease symptoms in patients with Meniere’s Disease.
Not Yet Recruiting
NCT06765993 — Efficacy and Safety of Isosorbide Oral Solution in Patients With Meniere’s Disease
| Status | Not yet recruiting |
| Phase | Phase 2 / Phase 3 |
| Sponsor | Lunan Better Pharmaceutical Co., LTD. |
| Enrollment | 234 |
| Study Type | INTERVENTIONAL |
| Conditions | Meniere´s Disease |
| Interventions | ; |
The purpose of this study is to evaluate the efficacy and safety of isosorbide oral solution compared with placebo in people with unilateral Meniere’s disease. A total of approximately 234 subjects will be enrolled in this study: 72 subjects in phase Ⅱ and approximately 162 subjects in phase Ⅲ. Patients were randomly assigned to either the experimental group or the control group. The randomizat…
Completed Trials
NCT00599560 — Vasopressin and V2 Receptor in Meniere’s Disease
| Status | Completed |
| Phase | N/A |
| Sponsor | Osaka University |
| Enrollment | 135 |
| Study Type | INTERVENTIONAL |
| Conditions | Meniere Disease |
| Interventions |
Summary: Some of sicknesses are well known to be provoked by inadequate adaptation to physical and/or psychogenic stress in their daily life. Meniere’s disease is also a common inner ear disease accompanied with vertigo, hearing loss and tinnitus especially in civilized people under stressed life style. Its oto-pathology was firstly revealed in 1938 to be inner ear endolymphatic hydrops through…
NCT00145483 — Sildenafil For Meniere’s Disease
| Status | Completed |
| Phase | Phase 4 |
| Sponsor | Pfizer’s Upjohn has merged with Mylan to form Viatris Inc. |
| Enrollment | 163 |
| Study Type | INTERVENTIONAL |
| Conditions | Meniere’s Disease |
| Interventions |
Meniere’s disease affects a person’s sense of balance. An attack can last 20 minutes to 2 hours or longer. Symptoms include rotational vertigo, hearing loss, tinnitus and a sensation of fullness in the affected ear and may be associated with nausea and vomiting. One hypothesis is that Meniere’s disease is caused by the excessive accumulation of fluid in the balance tubes within the inner ear. S…
NCT00802529 — Transtympanic Gentamicin vs. Steroids in Refractory Meniere’s Disease
| Status | Completed |
| Phase | Phase 2 / Phase 3 |
| Sponsor | Imperial College London |
| Enrollment | 60 |
| Study Type | INTERVENTIONAL |
| Conditions | Meniere’s Disease |
| Interventions | ; |
This trial aims to compare transtympanic steroids against the standard treatment (transtympanic gentamicin) in refractory unilateral Meniere’s disease.
NCT01084525 — OTO-104 for Meniere’s Disease
| Status | Completed |
| Phase | Phase 1 |
| Sponsor | Otonomy, Inc. |
| Enrollment | 44 |
| Study Type | INTERVENTIONAL |
| Conditions | Meniere’s Disease |
| Interventions | ; ; |
The purpose of this study is to evaluate the safety of OTO-104 in subjects with unilateral Meniere’s disease. The effectiveness of OTO-104 to reduce the symptoms of Meniere’s disease will also be evaluated.
NCT01574313 — Effect of Stellate Ganglion Block on Meniere’s Disease
| Status | Completed |
| Phase | Phase 4 |
| Sponsor | Chi Mei Medical Hospital |
| Enrollment | 20 |
| Study Type | INTERVENTIONAL |
| Conditions | Vertigo; Meniere Disease |
| Interventions | ; ; |
Stellate ganglion block (SGB) has been the alternative treatment of Meniere’s disease for years. However, objective evidence of the effect of SGB was still lack. The investigators conducted a randomized controlled study to examine the immediate effects of SGB in SP/AP of electrocochleography (ECoG).
NCT01454726 — Clinical Trial of Traditional Chinese Diaoshi Jifa Therapy of Meniere’s Disease
| Status | Completed |
| Phase | Phase 3 |
| Sponsor | Beijing Administration of Traditional Chinese Medicine Bureau |
| Enrollment | 27 |
| Study Type | INTERVENTIONAL |
| Conditions | Meniere’s Disease |
| Interventions | ; |
The hypothesis of this study is that DiaoShi Jifa reduces the symptoms, such as dizziness in patients with Meniere’s disease.
NCT01267994 — A Clinical Trial of Anakinra for Steroid-Resistant Autoimmune Inner Ear Disease
| Status | Completed |
| Phase | Phase 1 / Phase 2 |
| Sponsor | Andrea Vambutas |
| Enrollment | 13 |
| Study Type | INTERVENTIONAL |
| Conditions | Sensorineural Hearing Loss; Autoimmune Inner Ear Disease |
| Interventions |
The purpose of this study is to determine if Anakinra (an interleukin-1 receptor antagonist) can improve hearing thresholds in those patients with Autoimmune Inner Ear Disease (AIED) that did not respond to oral steroid therapy for a sudden decline in hearing. The patients to be enrolled will have recently completed a course of oral steroids and demonstrated no change in their audiometric thres…
NCT02080312 — Magnetic Resonance Imaging Evaluation of Inner Ear Pathology Using Intra-Tympanic Contrast Agent
| Status | Completed |
| Phase | N/A |
| Sponsor | University of California, San Diego |
| Enrollment | 6 |
| Study Type | INTERVENTIONAL |
| Conditions | Meniere’s Disease |
| Interventions |
This is a pilot study of patients with clinical symptoms of Ménière’s disease using injection of diluted magnetic resonance imaging (MRI) contrast agent into the ear to evaluate inner ear structures.
The goal is to reproduce imaging findings described by non-United States (US) institutions, improve on image quality with decreased scan time and evaluate the dynamics of the contrast movement int…
NCT02718846 — Isobide Solution and Meniace Tablets Compared to Monotherapy With Meniace Tablets
| Status | Completed |
| Phase | Phase 4 |
| Sponsor | Alvogen Korea |
| Enrollment | 220 |
| Study Type | INTERVENTIONAL |
| Conditions | Meniere’s Disease |
| Interventions | ; |
A multicenter, randomized, open-label clinical study with a concurrent control group to assess the effectiveness and safety of combined therapy with Isobide solution and Meniace tablets compared to monotherapy with Meniace tablets for patients with Meniere’s disease
NCT01950312 — The Effects of Gevokizumab in Corticosteroid-resistant Subjects With Autoimmune Inner Ear Disease
| Status | Completed |
| Phase | Phase 2 |
| Sponsor | XOMA (US) LLC |
| Enrollment | 10 |
| Study Type | INTERVENTIONAL |
| Conditions | Autoimmune Inner Ear Disease |
| Interventions |
The purpose of this study is to determine if gevokizumab therapy may be an alternate therapy in patients with steroid resistant Autoimmune Inner Ear Disease.
NCT01412177 — OTO-104 for the Treatment of Meniere’s Disease
| Status | Completed |
| Phase | Phase 2 |
| Sponsor | Otonomy, Inc. |
| Enrollment | 154 |
| Study Type | INTERVENTIONAL |
| Conditions | Meniere’s Disease |
| Interventions | ; |
The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere’s disease.
NCT02158585 — Study of Lamotrigine to Treat Ménière’s Disease
| Status | Completed |
| Phase | Phase 2 |
| Sponsor | Dent Neuroscience Research Center |
| Enrollment | 15 |
| Study Type | INTERVENTIONAL |
| Conditions | Meniere’s Disease; Ménière’s Vertigo; Vertigo, Intermittent; Vertigo, Aural |
| Interventions | ; |
This double-blinded study evaluates the frequency of vertigo attacks and the quality of life of patients diagnosed with Ménière’s disease after being randomly assigned to take a placebo or lamotrigine.
NCT02265393 — A 1-Year Safety Study of OTO-104 in Subjects With Unilateral Meniere’s Disease Located in United Kingdom
| Status | Completed |
| Phase | Phase 2 |
| Sponsor | Otonomy, Inc. |
| Enrollment | 128 |
| Study Type | INTERVENTIONAL |
| Conditions | Meniere’s Disease |
| Interventions | ; |
This is a 2-part study of OTO-104 in subjects with unilateral Meniere’s disease in the United Kingdom. The first part is a randomized, placebo-controlled study comparing the safety profile of 2 injections of OTO-104 or placebo spaced 3 months apart. The second part is an open-label extension where all subjects will receive an additional 2 intratympanic injections of OTO-104 spaced 3 months apar…
NCT02309099 — Cochlear Implantation After Labyrinthectomy or a Translabyrinthine Surgical Approach
| Status | Completed |
| Phase | N/A |
| Sponsor | University of North Carolina, Chapel Hill |
| Enrollment | 10 |
| Study Type | INTERVENTIONAL |
| Conditions | Unilateral Acoustic Neuroma; Meniere’s Disease |
| Interventions |
The goal of this project is to determine whether subjects who have undergone labyrinthectomy or a translabyrinthine surgical approach as the treatment for vestibular schwannoma or Meniere’s disease benefit from cochlear implantation on speech perception and localization tasks.
If the auditory nerve is able to transmit this signal effectively, then these two populations may be able to utilize t…
NCT02612337 — Study of OTO-104 in Subjects With Unilateral Meniere’s Disease
| Status | Completed |
| Phase | Phase 3 |
| Sponsor | Otonomy, Inc. |
| Enrollment | 166 |
| Study Type | INTERVENTIONAL |
| Conditions | Meniere’s Disease |
| Interventions | ; |
The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere’s disease.
NCT02603081 — Study to Evaluate SPI-1005 in Adults With Meniere’s Disease
| Status | Completed |
| Phase | Phase 1 / Phase 2 |
| Sponsor | Sound Pharmaceuticals, Incorporated |
| Enrollment | 40 |
| Study Type | INTERVENTIONAL |
| Conditions | Meniere’s Disease |
| Interventions |
This study will evaluate the safety and efficacy of three dose levels of SPI-1005 compared to placebo on vertigo, tinnitus and sensorineural hearing loss in 40 adults with Meniere’s disease.
NCT03215420 — Comparison of 3 Methods to Diagnose Endolymphatic Hydrops in Meniere’s Disease
| Status | Completed |
| Phase | N/A |
| Sponsor | Centre Hospitalier Universitaire Dijon |
| Enrollment | 41 |
| Study Type | INTERVENTIONAL |
| Conditions | Endolymphatic Hydrops |
| Interventions |
The aim of this study is to compare 3 methods for the diagnosis of endolymphatic hydrops (EH) in patients with Meniere’s disease: MRI 3 Tesla (to visualise EH directly), and functional explorations, namely electrocochleography and dephasing of acoustic distortion products (which are modified by the EH).
The research hypothesis is that the examinations will show agreement in the diagnosis of EH…
NCT03325790 — SPI-1005 for the Treatment of Patients With Meniere’s Disease
| Status | Completed |
| Phase | Phase 2 |
| Sponsor | Sound Pharmaceuticals, Incorporated |
| Enrollment | 149 |
| Study Type | INTERVENTIONAL |
| Conditions | Meniere’s Disease |
| Interventions | ; ; |
This study will evaluate the safety, efficacy, and Pharmacokinetics (PK) of two dose levels of SPI-1005 administered for 28 days compared to placebo in patients with Meniere’s disease.
NCT03664674 — Phase 3 Study of OTO-104 in Subjects With Unilateral Meniere’s Disease
| Status | Completed |
| Phase | Phase 3 |
| Sponsor | Otonomy, Inc. |
| Enrollment | 148 |
| Study Type | INTERVENTIONAL |
| Conditions | Meniere Disease |
| Interventions | ; |
The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere’s disease.
NCT04218123 — Assessing the Efficacy of a Serotonin and Norepinephrine Reuptake Inhibitor for Improving Meniere’s Disease Outcomes
| Status | Completed |
| Phase | Phase 2 / Phase 3 |
| Sponsor | Medical University of South Carolina |
| Enrollment | 40 |
| Study Type | INTERVENTIONAL |
| Conditions | Meniere Disease |
| Interventions | ; |
As of yet, the cause of Meniere’s disease is uncertain and there is no cure. Given the lack of high level evidence for treatments, we seek to perform a randomized, placebo-controlled, double-blind, crossover, pilot trial of venlafaxine for treating Meniere’s disease. Venlafaxine is a safe and well-tolerated medication. It has never been trialed in Meniere’s disease, but there is evidence that i…
NCT04569175 — Non Enhanced Labyrinth Imaging for the Detection of Endolymphatic Hydrops in Meniere’s Disease “NELI Study”
| Status | Completed |
| Phase | N/A |
| Sponsor | University Hospital, Bordeaux |
| Enrollment | 14 |
| Study Type | INTERVENTIONAL |
| Conditions | Meniere Disease |
| Interventions |
This study includes 30 patients with Meniere’s disease confirmed with AAO-HNS criteria.
The aim of this study is to compare the new optimized 3D FLAIR sequence developed at our site with a standard 3D FLAIR sequence performed 4h after a single intravenous dose of macrocyclic gadolinium-based contrast agents for the detection of endolymphatic hydrops.
The patients will be explored with the new…
NCT04869020 — Evaluation of the OtoBand in Subjects With Self-reported Vertigo to Reduce Severity of Vertigo in a Real-world Setting
| Status | Completed |
| Phase | N/A |
| Sponsor | Otolith Labs |
| Enrollment | 40 |
| Study Type | INTERVENTIONAL |
| Conditions | Vertigo |
| Interventions | ; ; |
This study seeks to gather data on the effect of a device, the OtoBand, in participants who have reported symptoms of vertigo, compared to the effect of using one of two sham devices. The study is designed to be conducted remotely using video conferencing between representatives of the manufacturer of the Otoband and participants. In order to comply with requirements for non-essential contact d…
NCT04677972 — SPI-1005 for the Treatment of Meniere’s Disease
| Status | Completed |
| Phase | Phase 3 |
| Sponsor | Sound Pharmaceuticals, Incorporated |
| Enrollment | 254 |
| Study Type | INTERVENTIONAL |
| Conditions | Meniere Disease; Ménière |
| Interventions | ; |
The study is a randomized, double-blind, placebo-controlled, multi-center clinical trial (RCT) with open-label extension study (OLE), of SPI-1005 in adult subjects with definite Meniere’s disease with active symptoms within three months preceding study enrollment.
NCT05844657 — Comprehensive Evaluation in Patients With Meniere’s Disease
| Status | Completed |
| Phase | N/A |
| Sponsor | Hacettepe University |
| Enrollment | 34 |
| Study Type | OBSERVATIONAL |
| Conditions | Meniere Disease; Psychosocial Problem; Physical Disability; Quality of Life |
| Interventions | ; ; |
The aim of our study is to determine the severity of the disease in people with Meniere’s Disease; physical conditions such as balance, posture, pain, physical activity level, neck joint range of motion, proprioception; to examine psychosocial conditions such as depression, anxiety, sleep quality, fatigue, and quality of life and to make a comprehensive evaluation by comparing it with healthy v…
Other (Unknown)
NCT01729767 — Efficacy of Antiviral Medications in Controlling Vertigo Attacks of Patients With Meniere’s Disease
| Status | Unknown |
| Phase | Phase 2 / Phase 3 |
| Sponsor | Tehran University of Medical Sciences |
| Enrollment | 80 |
| Study Type | INTERVENTIONAL |
| Conditions | Meniere’s Disease |
| Interventions | ; |
Meniere’s disease is a chronic illness that affects a substantial number of patients every year worldwide. The disease is characterized by intermittent episodes of vertigo lasting from minutes to hours, with fluctuating sensorineural hearing loss, tinnitus, and aural pressure. It has recently been suggested that viral etiologies specially Herpes virus might be the underlying reason. The investi…
Other (Terminated)
NCT01526408 — Famvir for Treatment of Hearing in Unilateral Meniere’s Disease
| Status | Terminated |
| Phase | Phase 3 |
| Sponsor | House Research Institute |
| Enrollment | 11 |
| Study Type | INTERVENTIONAL |
| Conditions | Meniere’s Disease |
| Interventions | ; |
The specific aim of this study is to determine the efficacy of treatment with famciclovir in unilateral Meniere’s Disease patients, specifically whether hearing can be improved. The investigators will determine the percentage of unilateral Meniere’s Disease patients experiencing an absence of hearing fluctuation after 3 months of treatment with famciclovir as compared to the placebo arm.
NCT02706730 — A 6-Month Extension Study of OTO-104 in Meniere’s Disease
| Status | Terminated |
| Phase | Phase 3 |
| Sponsor | Otonomy, Inc. |
| Enrollment | 189 |
| Study Type | INTERVENTIONAL |
| Conditions | Meniere’s Disease |
| Interventions |
This is an open-label extension study of a single intratympanic injection of OTO-104 given every 3 months for a total of 2 injections. Subjects must have completed either Otonomy study 104-201102 (Phase 2b study of OTO-104) or 104-201506 (Phase 3 study of OTO-104) in order to be eligible for this open-label extension study.
NCT02530931 — Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Patients With Meniere’s Disease
| Status | Terminated |
| Phase | Phase 4 |
| Sponsor | University Hospital, Grenoble |
| Enrollment | 23 |
| Study Type | INTERVENTIONAL |
| Conditions | Meniere’s Disease |
| Interventions |
- This prospective study aims to better characterize inner ear’s perilymphatic structures with Magnetic Resonance Imaging using contrast media and delayed injection in patient’s with Meniere’s disease.
- MR Perfusion Imaging will be assess in both cochlea as well
- Primary auditory brain pathways will be evaluated through MR diffusion imaging
NCT02717442 — Study of OTO-104 in Subjects With Unilateral Meniere’s Disease
| Status | Terminated |
| Phase | Phase 3 |
| Sponsor | Otonomy, Inc. |
| Enrollment | 176 |
| Study Type | INTERVENTIONAL |
| Conditions | Meniere’s Disease |
| Interventions | ; |
The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere’s disease.
NCT02740387 — Open Label Study of OTO-104 in Subjects With Meniere’s Disease
| Status | Terminated |
| Phase | Phase 2 |
| Sponsor | Otonomy, Inc. |
| Enrollment | 34 |
| Study Type | INTERVENTIONAL |
| Conditions | Meniere’s Disease |
| Interventions |
This is a 1-year, multicenter, Phase 2, open-label safety study in subjects with unilateral Meniere’s disease. Subjects will receive 1 intratympanic (IT) injection of 12 mg OTO-104 at 3-month intervals for a total of 4 injections total.
NCT02768662 — A 6-Month Extension Study of OTO-104 in Meniere’s Disease
| Status | Terminated |
| Phase | Phase 3 |
| Sponsor | Otonomy, Inc. |
| Enrollment | 142 |
| Study Type | INTERVENTIONAL |
| Conditions | Meniere’s Disease |
| Interventions |
This is an open-label extension study of a single intratympanic injection of OTO-104 given every 3 months for a total of 2 injections. Subjects must have completed either Otonomy study 104-201403 (1-Year, Phase 2, Safety Study of OTO-104) or 104-201508 (Phase 3 Study of OTO-104) in order to be eligible for this open-label extension study.
NCT06278129 — Evaluation of the Diagnostic and Prognostic Efficacy of MRI in Acute Sensorineural Hearing Loss and Ménière’s Disease
| Status | Unknown |
| Phase | N/A |
| Sponsor | Fondazione IRCCS Ca’ Granda, Ospedale Maggiore Policlinico |
| Enrollment | 64 |
| Study Type | OBSERVATIONAL |
| Conditions | Sudden Sensorineural Hearing Loss; Meniere Disease; Ménière’s Vertigo; Meniere’s Disease Aggravated; Inner Ear Disease |
| Interventions |
Evaluation of the diagnostic and prognostic efficacy of nuclear magnetic resonance imaging in patients with acute sensorineural hearing loss or in patients suffering from probable or definite MD. The neuroradiological and audiological evaluation are held on in the same day in order to better clarify the radiological and clinical correlates.
Other (Suspended)
NCT04026516 — CAVA: Dizziness Trial
| Status | Suspended |
| Phase | N/A |
| Sponsor | Julie Dawson |
| Enrollment | 35 |
| Study Type | INTERVENTIONAL |
| Conditions | Meniere’s Disease; Benign Paroxysmal Positional Vertigo; Recurrent Vestibulopathy; Vestibular Migraine |
| Interventions |
Clinical investigation of a medical device (CAVA) for recording eye movements. Patients suffering from diagnosed dizziness conditions will wear the device for 23 hours a day, for 30 days. The device will capture normal eye movement data as well as data corresponding to any dizzy events experienced. At the end of the trial, the data will be downloaded and a scientist will perform a blinded analy…
NCT05420350 — Lamotrigine and Bupropion for Meniere’s Disease
| Status | Unknown |
| Phase | Phase 2 |
| Sponsor | Dent Neuroscience Research Center |
| Enrollment | 34 |
| Study Type | INTERVENTIONAL |
| Conditions | Meniere Disease; Ménière’s Vertigo; Vertigo, Intermittent; Vertigo, Aural |
| Interventions | ; |
This is a double-blind, placebo-controlled clinical trial to assess whether treatment with lamotrigine and bupropion is more effective than placebo to reduce definitive Meniere’s vertigo attacks (DMVA) and dizziness in patients with Meniere’s disease. Thirty four participants will be randomized to treatment or placebo groups. Each participant will take part in the trial for 34 weeks, or approxi…
NCT05355610 — Vestibular Rehabilitation With Intratympanic Drug Therapy in Meniere’s Disease
| Status | Unknown |
| Phase | N/A |
| Sponsor | Combined Military Hospital Quetta |
| Enrollment | 93 |
| Study Type | INTERVENTIONAL |
| Conditions | Vestibular Disorder Preservation |
| Interventions | ; |
Intractable symptoms of Meniere’s disease will be treated with intratympanic steroids.
At the same time intratympanic dexamethasone will be used to rescue hearing
NCT04847700 — Minimally Invasive Vestibular Neurectomy Versus Tenotomy of the Stapedius and Tensor Tympani Muscles in the Management of Patients With Unilateral Meniere’s Disease
| Status | Unknown |
| Phase | N/A |
| Sponsor | Mansoura University |
| Enrollment | 30 |
| Study Type | INTERVENTIONAL |
| Conditions | Ménière |
| Interventions | ; |
The distinctive symptoms of Meniere’s disease (MD) include recurrent vertigo spells, fluctuating hearing loss, aural fullness and tinnitus. Conservative treatment in MD comprises lifestyle modifications, such as low-sodium diet, avoidance of caffeine, alcohol and stress, in addition to medication such as diuretics and betahistine. When conservative treatment fails, surgical management is attemp…
NCT04949321 — Acceleration of the Kinetics of Diffusion of Gadolinium in the Perilymphatic Structures of the Inner Ear.
| Status | Unknown |
| Phase | N/A |
| Sponsor | University Hospital, Grenoble |
| Enrollment | 80 |
| Study Type | INTERVENTIONAL |
| Conditions | Inner Ear ; Meniere’s Disease; Imaging |
| Interventions |
To determine the optimal delay after Gadolinium injection to analysis inner ear structures as measured by repeated MR 3D-FLAIR Weighted Imaging. We hypothesize that the endolymphatic structures can be distinguished earlier than 4 hours after contrast media injection.
Other (Withdrawn)
NCT04674735 — Safety of APSLXR in Patients Presenting Vertigo of Vestibular Origin or Meniere’s Disease
| Status | Withdrawn |
| Phase | Phase 1 |
| Sponsor | Apsen Farmaceutica S.A. |
| Enrollment | N/A |
| Study Type | INTERVENTIONAL |
| Conditions | Meniere Disease; Vertigo; Vertigo Vestibular |
| Interventions |
The purpose of this study is to evaluate the safety of APSLXR in participants with Meniere’s disease or other Verigo of vestibular origin. Pharmacokinetics will also be evaluated in a small group.
NCT06143462 — Vestibular Rehabilitation for Unsteadiness After Intratympanic Gentamicin in Patients With Meniere’s Disease
| Status | Unknown |
| Phase | N/A |
| Sponsor | Eye & ENT Hospital of Fudan University |
| Enrollment | 48 |
| Study Type | INTERVENTIONAL |
| Conditions | Vestibular Disorder |
| Interventions | ; ; |
To investigate the efficacy of vestibular rehabilitation treatment on unsteadiness after intratympanic gentamicin in patients with Meniere’s disease.