E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
refractory unilateral Meniere's disease |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000641 |
E.1.2 | Term | Active Meniere's disease, cochleovestibular |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
There are 20-24% of patients with Meniere's disease who do not respond to first line treatment with diet modification and oral drugs. One of the well established alternative treatment option is the minimally invasive transtympanic treatment, where drugs are injected locally through the ear drum. The most commonly used drug for injection is Gentamicin. Gentamicin provides effective control of vertigo by toxic action on the labyrinth. But it is potentially harmful to hearing organ also and may produce further hearing deterioration in 25% of patients and profound loss in 7%. Recently, steroids are used as an alternative by many ENT surgeons with reports that it provides relief of vertigo without hearing loss or maybe hearing improvemnet also. However, this has not been proven. The main research question is to compare the two drugs and establish their role in Meniere's patients who are not responding to medical treatment. |
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E.2.2 | Secondary objectives of the trial |
There are two more objectives in these proposals. The first one relates to effectiveness of steroids in immune mediated disorders. Hence, we will look for the presence of inner ear-specific immune mediated Ménière's disease in our patients with new techniques (inner ear specific Western blot) and note their response to steroids. If the patients with better response to the transtympanic steroids show abnormal inner ear immunity in our tests, then these tests could be used in the future as a predictor of response to steroids. The second one is to apply a new vestibular test during the trial in Ménière's disease. This test, called the utricular centrifugation test, allows quantification of unilateral vestibular function as needed in these group of patients. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with unilateral Ménière's disease (definite or probable, according to AAO-HNS criteria 1995) in Shea stages II and III (i.e. with hearing loss and presenting with recurrent vertigo) not responding to medical treatment for at least 6 months will be included. |
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E.4 | Principal exclusion criteria |
a)Patients with Ménière's disease in later stages (not having vertigo attacks). b)Age: patients older than 70 years at the start of the trial. c)Severe disability (e.g. neurological, orthopaedic, cardiovascular) or serious concurrent illness that might interfere with treatment or follow up. d)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. e)Concurrent ear pathology that may interfere with TT (e.g. active middle ear disease). f)Family history of unexplained deafness (possibility of genetic susceptibility to gentamicin toxicity). g)History of known adverse/allergic reaction to steroids or gentamicin.
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E.5 End points |
E.5.1 | Primary end point(s) |
relief from vertigo attacks as determined by validated questionnaires and as per committee of hearing and equilibrium guidelines. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |