---
title: "Transtympanic Gentamicin vs. Steroids in Refractory Meniere's Disease"
nct_id: NCT00802529
overall_status: COMPLETED
phase: PHASE2, PHASE3
sponsor: Imperial College London
study_type: INTERVENTIONAL
primary_condition: "Meniere's Disease"
countries: United Kingdom
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00802529.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00802529"
ct_last_update_post_date: 2019-06-27
last_seen_at: "2026-05-12T06:24:21.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Transtympanic Gentamicin vs. Steroids in Refractory Meniere's Disease

**Official Title:** Effectiveness of Transtympanic Steroids in Unilateral Ménière's Disease: a Randomised Controlled Double-Blind Trial

**NCT ID:** [NCT00802529](https://clinicaltrials.gov/study/NCT00802529)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2, PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 60
- **Lead Sponsor:** Imperial College London
- **Collaborators:** Imperial College Healthcare NHS Trust, Medical Research Council
- **Conditions:** Meniere's Disease
- **Start Date:** 2009-04
- **Completion Date:** 2015-05
- **CT.gov Last Update:** 2019-06-27

## Brief Summary

This trial aims to compare transtympanic steroids against the standard treatment (transtympanic gentamicin) in refractory unilateral Meniere's disease.

## Detailed Description

Meniere's disease is characterised 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 ear drum 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 drug 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 randomised, double blind trial.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 70 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Patients with unilateral Ménière's disease (definite or probable, according to Committee on Hearing and Equilibrium guidelines, 1995) with hearing loss and presenting with recurrent vertigo, not responding to medical treatment for at least 6 months will be included. There should be normal, age appropriate hearing in the contralateral ear.

Exclusion Criteria:

* Patients with Ménière's disease in later stages (not having vertigo attacks).
* Age: patients older than 70 years at the start of the trial.
* Severe disability (e.g. neurological, orthopaedic, cardiovascular) or serious concurrent illness that might interfere with treatment or follow up.
* Active additional neuro-otological disorders that may mimic Ménière's disease (e.g. vestibular migraine, vertebro-basilar TIAs, acoustic neuroma) and thus will make the objective follow up difficult.
* Concurrent ear pathology that may interfere with transtympanic treatment (e.g. active middle ear disease).
* Family history of unexplained deafness (possibility of genetic susceptibility to gentamicin toxicity).
* History of known adverse/allergic reaction to steroids or gentamicin.
```

## Arms

- **Steroid (Methylprednisolone)** (EXPERIMENTAL) — Steroid (Methylprednisolone)
- **Gentamicin** (ACTIVE_COMPARATOR) — Gentamicin

## Interventions

- **Methylprednisolone** (DRUG) — 2 transtympanic injections at interval of two weeks.
- **Gentamicin** (DRUG) — 2 transtympanic injections at an interval of two weeks. If there is significant hearing loss before second injection, it will be replaced by normal saline in double blinded fashion.

## Primary Outcomes

- **Vertigo Attacks** _(time frame: 6month pre-enrollment baseline, 18-24 months after initial treatment)_ — The number of vertigo attacks between 18-24months 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).

## Secondary Outcomes

- **Change in Hearing** _(time frame: Baseline, 1,2,6,12,18 and 24months after initial treatment)_
- **Change in Speech Discrimination** _(time frame: Baseline, 1,2,6,12 and 24months after initial treatment)_

## Locations (1)

- Imperial college Healthcare NHS Trust, London, United Kingdom

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.imperial college healthcare nhs trust|london||united kingdom` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00802529.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00802529*  
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