Ménière’s disease is a chronic inner ear disorder that affects balance and hearing, often causing vertigo, tinnitus, and hearing loss. While its exact cause remains unclear, the condition can significantly impact quality of life, prompting ongoing research to better understand and manage it.
Over the years, various clinical trials have been conducted to explore potential treatments and therapies aimed at alleviating symptoms and improving patient outcomes. In the following section, we will provide an overview of key clinical trials, shedding light on the advancements being made in the quest to treat Ménière’s disease effectively.
Quick View Table of Meniere’s Disease Clinical Trials
Meniere’s Disease Clinical Trials
SPI-1005 for the Treatment of Meniere’s Disease (STOPMD-3)
- Sponsor: Sound Pharmaceuticals, Incorporated
- Summary: 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.
- Intervention/Treatment: Ebselen vs. Placebo
- Primary Outcome Measures:
- Incidence of Treatment-Emergent Adverse Events [84 days]
- Safety and tolerability assessed based on comparison of adverse events vs. placebo
- Change in low frequency hearing thresholds measured by pure tone audiometry [56 days]
- Co-primary efficacy endpoint; assessment of hearing by pure tone audiometry
- Change in Words-in-Noise Test score [56 days]
- Co-primary efficacy endpoint; assessment of word recognition by Words-in-Noise Test
- Incidence of Treatment-Emergent Adverse Events [84 days]
Assessing the Efficacy of a Serotonin and Norepinephrine Reuptake Inhibitor for Improving Meniere’s Disease Outcomes
- Sponsor: Medical University of South Carolina
- Summary: 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 it could be effective in helping with vertigo attacks and other aspects of the disorder.
- Intervention/Treatment: Venlafaxine vs. Placebo oral tablet
- Primary Outcome Measures:
- Number of Vertigo Episodes [6 months]
- Patients will be keeping a diary throughout the study period and beyond.
- Severity of Vertigo [6 months]
- The study team will use a modified version of vertigo control classification because the treatment phases are 2 months long and the study team will not be able to wait 18-24 months after treatment to assess efficacy per academy guidelines. Previous studies have defined four categories of response to treatment: 1) very good response if more than 75% reduction in vertigo spells frequency and/or intensity, 2) good response if 50-75% reduction, 3) fair response if 25-50% reduction, and 4) poor response if less than 25% reduction.
- The vertigo classes will be defined as follows; Class A: 0 (complete control of vertigo) Class B: 0-40 or >60% reduction in mean vertigo episode severity (good control of vertigo) Class C: 41-80 or 20-60% reduction in severity (fair control of vertigo) Class D: 81-120 or -20-20% reduction in severity (no change in vertigo) Class E: >120 or >20% worsening in severity (worse vertigo)
- Number of Vertigo Episodes [6 months]
The Effecttiveness of Intratympanic Methylprednisolon Injections Compared to Placebo in the Treatment of Vertigo Attacks in Meniere’s Disease (PREDMEN)
- Sponsor: Leiden University Medical Center
- Summary: 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 treatment. This multicenter trial compares a patient group which receives injections of methylprednisolone to a patient group which receives placebo injections. Subsequently, dizziness, tinnitus, hearing loss and quality of life will be assed and compared for the above mentioned groups, over a period of one year.
- Intervention/Treatment: Methylprednisolon vs. Placebo
- Primary Outcome Measures:
- Vertigo spells [Daily, change from baseline to one year]
- A definitive vertigo spell is defined as a spontaneous rotational vertigo symptom, which lasts at least 20 minutes and is often accompanied by disequilibrium and vomiting. No loss of consciousness is present. Vertigo spells are measured daily with the dizzy quest ap. Furthermore, at baseline after 6 and 12 months, caloric testing and a video-head impulse test are performed. Additionally the dizziness handicap inventory will be taken.
- Vertigo spells [Daily, change from baseline to one year]
A 6-Month Extension Study of OTO-104 in Meniere’s Disease
- Sponsor: Otonomy, Inc.
- Summary: 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.
- Intervention/Treatment: OTO-104
- Primary Outcome Measures:
- Otoscopic Examination – Tympanic Membrane Perforation at Week 24 (Month 6) [6 Months]
- Otoscopic exams were conducted at each visit. It was considered important to understand if the tympanic membrane perforation that resulted from the IT injection persisted at the end of study visit (24 Weeks [Month 6]).
- Otoscopic Examination – Tympanic Membrane Perforation at Week 24 (Month 6) [6 Months]
Study of OTO-104 in Subjects With Unilateral Meniere’s Disease (AVERTS-2)
- Sponsor: Otonomy, Inc.
- Summary: The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere’s disease.
- Intervention/Treatment: OTO-104 vs. Placebo
- Primary Outcome Measures:
- The Number of DVD at Week 12 (the 4-week [28 Days] Interval From Week 9 Through Week 12) – FAS-1 Population [3 months]
- In the Full Analysis Set (FAS)-1 population, the number of DVDs at Week 12 (the 4-week [28 days] interval from Week 9 through Week 12) was compared between OTO-104 and placebo. Week 12 = 12 weeks after dosing at the Baseline visit. The Baseline visit occurred at the end of lead-in. No intervention was administered during lead-in.
- The Number of DVD at Week 12 (the 4-week [28 Days] Interval From Week 9 Through Week 12) – FAS-2 Population [3 months]
- The number of DVDs at Week 12 (the 4-week [28 days] interval from Week 9 through Week 12) was compared between OTO-104 and placebo. Week 12 = 12 weeks after dosing at the Baseline visit. The Baseline visit occurred at the end of lead-in. No intervention was administered during lead-in.
- The Number of DVD at Week 12 (the 4-week [28 Days] Interval From Week 9 Through Week 12) – FAS-1 Population [3 months]
Study of OTO-104 in Subjects With Unilateral Meniere’s Disease (AVERTS-1)
- Sponsor: Otonomy, Inc.
- Summary: The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere’s disease.
- Intervention/Treatment: OTO-104 vs. Placebo
- Primary Outcome Measures:
- The Number of DVD at Week 12 (Defined as the 4-week [28 Days] Interval From Week 9 Through Week 12). [Week 12 (3 months)]
- The number of DVDs at Week 12 (defined as the 4-week [28 days] interval from Week 9 through Week 12) was compared between OTO-104 and placebo.
- Week 12 = 12 weeks after dosing at the Baseline visit. Baseline occurred at the end of lead-in and no intervention was administered during lead-in.
- The Number of DVD at Week 12 (Defined as the 4-week [28 Days] Interval From Week 9 Through Week 12). [Week 12 (3 months)]
A 6-Month Extension Study of OTO-104 in Meniere’s Disease
- Sponsor: Otonomy, Inc.
- Summary: 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.
- Intervention/Treatment: OTO-104
- Primary Outcome Measures:
- Otoscopic Examination – Tympanic Membrane Perforation at Week 24 (Month 6) [6 Months]
- Otoscopic examinations were conducted at each visit. It was considered important to understand if the tympanic perforation that resulted from the IT injection persisted at the end of study visit (Week 24 [Month 6]).
- Otoscopic Examination – Tympanic Membrane Perforation at Week 24 (Month 6) [6 Months]
Phase 3 Study of OTO-104 in Subjects With Unilateral Meniere’s Disease
- Sponsor: Otonomy, Inc.
- Summary: The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere’s disease.
- Intervention/Treatment: OTO-104 vs. Placebo
- Primary Outcome Measures:
- 28-Day Average DVD at Week 12 (Month 3) [3 months]
- The count of definitive vertigo days for Week 12 was determined during the 4-week period between Weeks 9 and 12. The 28-day average DVD was derived for each subject and visit by summing each subject’s number of DVD counts within the 4-week interval, dividing by the number of completed diary days, and multiplying by 28.
- 28-Day Average DVD at Week 12 (Month 3) [3 months]
Famvir for Treatment of Hearing in Unilateral Meniere’s Disease (Famvir)
- Sponsor: House Research Institute
- Summary: 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.
- Intervention/Treatment: Famciclovir vs. Placebo
- Primary Outcome Measures:
- Pure-tone Threshold Change [3 months]
- Change in hearing from baseline to after 3 months of treatment
- Pure-tone Threshold Change [3 months]
Transtympanic Gentamicin vs. Steroids in Refractory Meniere’s Disease
- Sponsor: Imperial College London
- Summary: Meniere’s disease is characterized by episodic spontaneous vertigo attacks with hearing loss, ringing sounds and fullness in the ear. In one out of five patients, standard first line medical treatment is not effective in controlling vertigo attacks. For these incapacitated patients, gentamicin injections through the eardrum is a well established minimally invasive treatment. Major surgery of the balance organs or nerve, risking complete hearing loss, CSF leak, meningeal infections, are rarely performed nowadays. Gentamicn is very effective in controlling vertigo and acts by chemical ablation of end organs. As hearing and balance organs are entwined around each other, gentamicin treatment does not come without the risk of hearing loss. In fact, meta-analysis shows hearing deterioration in 13% to 35% percent of gentamicin treated patients. On the other hand, steroids are drugs of choice for autoimmune inner ear disease and commonly used for sudden hearing loss. They are non toxic drugs without any known side effects during local treatment in ear. We will compare the two in this randomized, double blind trial.
- Intervention/Treatment: Methylprednisolone vs. Gentamicin
- Primary Outcome Measures:
- Vertigo Attacks [6 month pre-enrollment baseline, 18-24 months after initial treatment]
- The number of vertigo attacks between 18-24 months follow-up were taken retrospectively during a face-to-face appointment at 24 months follow-up and compared to 6 month pre-enrollment baseline (as per Committee on Hearing and Equilibrium guidelines).
- Vertigo Attacks [6 month pre-enrollment baseline, 18-24 months after initial treatment]
As our understanding of Ménière’s Disease evolves, so too does the possibility of improved treatments that can alleviate symptoms and enhance the quality of life for patients. By staying informed and engaged with the latest developments in Ménière’s research, healthcare professionals and patients can remain hopeful for a future where this condition can be more effectively treated.
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