Back to resultsTranstympanic Gentamicin vs. Steroids in Refractory Meniere's Disease
Primary Purpose
Meniere's Disease
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Methylprednisolone
Gentamicin
Sponsored by
About this trial
This is an interventional treatment trial for Meniere's Disease focused on measuring Meniere's disease, transtympanic steroids, Randomised controlled trial
Eligibility Criteria
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.
Sites / Locations
- Imperial college Healthcare NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Steroid (Methylprednisolone)
Gentamicin
Arm Description
Steroid (Methylprednisolone)
Gentamicin
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Change in Hearing
Hearing was measured as ipsilesional pure-tone threshold at Baseline, 1month, 2months, 6months, 12month, 18months and 24 months follow-up. Hearing level was taken as the average threshold across 0.5, 1, 2 and 3KHz.
Change in Speech Discrimination
Speech discrimination was measured at Baseline, 1month, 2months, 6months, 12month and 24 months follow-up.
Speech discrimination was assessed by means of ipsilesional suprathreshold word recognition (%). Arthur Boothroyd's isophonemic word lists (AB wordlists, Guymark, Southampton) comprising sets of 10 words were played to the ipsilesional ear at the low-frequency pure-tone threshold of 0·5, 1 and 2 kHz +30dB with masking sound in the contralesional ear if necessary. The formula for masking level was: low-frequency pure-tone threshold in ipsilesional ear - bone conduction mean threshold (0·5, 1 and 2KHz) in contralesional ear - 40dB. Speech loudness and masking were rounded to the nearest 5dB. Step increments and decrements of 10dB for speech loudness and masking were used to attain the maximum speech discrimination score.
Full Information
NCT ID
NCT00802529
First Posted
December 4, 2008
Last Updated
June 19, 2019
Sponsor
Imperial College London
Collaborators
Imperial College Healthcare NHS Trust, Medical Research Council
1. Study Identification
Unique Protocol Identification Number
NCT00802529
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
Imperial College Healthcare NHS Trust, Medical Research Council
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meniere's Disease
Keywords
Meniere's disease, transtympanic steroids, Randomised controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Steroid (Methylprednisolone)
Arm Type
Experimental
Arm Description
Steroid (Methylprednisolone)
Arm Title
Gentamicin
Arm Type
Active Comparator
Arm Description
Gentamicin
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Intervention Description
2 transtympanic injections at interval of two weeks.
Intervention Type
Drug
Intervention Name(s)
Gentamicin
Intervention Description
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 Outcome Measure Information:
Title
Vertigo Attacks
Description
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).
Time Frame
6month pre-enrollment baseline, 18-24 months after initial treatment
Secondary Outcome Measure Information:
Title
Change in Hearing
Description
Hearing was measured as ipsilesional pure-tone threshold at Baseline, 1month, 2months, 6months, 12month, 18months and 24 months follow-up. Hearing level was taken as the average threshold across 0.5, 1, 2 and 3KHz.
Time Frame
Baseline, 1,2,6,12,18 and 24months after initial treatment
Title
Change in Speech Discrimination
Description
Speech discrimination was measured at Baseline, 1month, 2months, 6months, 12month and 24 months follow-up.
Speech discrimination was assessed by means of ipsilesional suprathreshold word recognition (%). Arthur Boothroyd's isophonemic word lists (AB wordlists, Guymark, Southampton) comprising sets of 10 words were played to the ipsilesional ear at the low-frequency pure-tone threshold of 0·5, 1 and 2 kHz +30dB with masking sound in the contralesional ear if necessary. The formula for masking level was: low-frequency pure-tone threshold in ipsilesional ear - bone conduction mean threshold (0·5, 1 and 2KHz) in contralesional ear - 40dB. Speech loudness and masking were rounded to the nearest 5dB. Step increments and decrements of 10dB for speech loudness and masking were used to attain the maximum speech discrimination score.
Time Frame
Baseline, 1,2,6,12 and 24months after initial treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adolfo M Bronstein, PhD, FRCP
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imperial college Healthcare NHS Trust
City
London
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
27865535
Citation
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.
Results Reference
derived
Learn more about this trial
Transtympanic Gentamicin vs. Steroids in Refractory Meniere's Disease
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