Transtympanic Gentamicin vs. Steroids in Refractory Meniere's Disease

NCT00802529 | Completed Phase 2 Results

• 1 other identifier: CRO1135
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Meniere's Disease

Keywords

Meniere's disease; transtympanic steroids; Randomised controlled trial

Outcome Measures

Primary Outcomes (1)

• Vertigo Attacks

  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).

  6month pre-enrollment baseline, 18-24 months after initial treatment

Secondary Outcomes (2)

• Change in Hearing

  Baseline, 1,2,6,12,18 and 24months after initial treatment

• Change in Speech Discrimination

  Baseline, 1,2,6,12 and 24months after initial treatment

Study Arms (2)

Steroid (Methylprednisolone)

EXPERIMENTAL

Steroid (Methylprednisolone)

Drug: Methylprednisolone

Gentamicin

ACTIVE COMPARATOR

Gentamicin

Drug: Gentamicin

Interventions

Methylprednisolone DRUG

2 transtympanic injections at interval of two weeks.

Steroid (Methylprednisolone)

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.

Gentamicin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College London: lead
• Imperial College Healthcare NHS Trust: collaborator
• Medical Research Council: collaborator

Study Sites (1)

Imperial college Healthcare NHS Trust

London, United Kingdom

Location

Related Publications (2)

• Sjogren J, Fransson PA, Magnusson M, Karlberg M, Tjernstrom F. Acute unilateral vestibulopathy and corticosteroid treatment - A randomized placebo-controlled double-blind trial. J Vestib Res. 2025 Mar;35(2):91-101. doi: 10.1177/09574271241307649. Epub 2024 Dec 18.

  PMID: 39973595 DERIVED

• Patel M, Agarwal K, Arshad Q, Hariri M, Rea P, Seemungal BM, Golding JF, Harcourt JP, Bronstein AM. Intratympanic methylprednisolone versus gentamicin in patients with unilateral Meniere's disease: a randomised, double-blind, comparative effectiveness trial. Lancet. 2016 Dec 3;388(10061):2753-2762. doi: 10.1016/S0140-6736(16)31461-1. Epub 2016 Nov 17.

  PMID: 27865535 DERIVED

MeSH Terms

Conditions

Meniere Disease

Interventions

Methylprednisolone; Gentamicins

Condition Hierarchy (Ancestors)

Endolymphatic Hydrops; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: Professor Adolfo Bronstein (Clinical professor and Head of neuro-otology group)
• Organization: Imperial College London

a.bronstein@imperial.ac.uk

(0)20 3313 5525

Study Officials

• Adolfo M Bronstein, PhD, FRCP

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2008
• First Posted: December 5, 2008
• Study Start: April 1, 2009
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 27, 2019
• Results First Posted: October 24, 2016

Record last verified: 2019-06

Locations

GB (1)