E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Menière´s disease. A disease associated with vertigo attacks, tinnitus and hearing loss. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Ear, nose and throat diseases [C09] |
MedDRA Classification |
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 |
The primary objective is to determine the efficacy and duration of action of latanoprost as treatment of Menière’s disease |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to determine the safety of latanoprost as a treatment of Menière’s disease. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
˗ At least 18 years of age
˗ Definite unilateral Menière’s disease (AAO-HNS 1995)
˗ Disease stage II-IV: PTA4 (pure tone average at 4 frequencies, 0.5, 1.0, 2.0, and 3.0 kHz) > 25 dB (AAO-HNS 1995).
˗ Speech discrimination score in silence (using 50 Swedish PB words) no better than 85%. The signal level at the first measurement (Visit 1) is to be adjusted to each patient’s most comfortable level. This signal level is to be applied at the second measurement (Visit 2a/Day 1).
˗ At least three vertigo attacks (lasting ≥ 20 minutes) during the three last months prior to inclusion
˗ Tinnitus during the last three months prior to inclusion
- Written informed consent
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E.4 | Principal exclusion criteria |
˗ Any medical or psychiatric condition, which could jeopardize or would compromise the subject’s ability to participate in this trial or decrease the likelihood of obtaining satisfactory data to achieve the objective of the trial e.g. dementia, alcohol or substance abuse
˗ Bilateral Menière’s disease
˗ Chronic otitis media on the ear affected by Menière’s disease
˗ Subjects not fluent in the Swedish language
˗ Bronchial asthma
˗ Previous intratympanic gentamicin or surgical therapy
˗ Previous intratympanic steroid therapy less than six months prior to inclusion
- Known hypersensitivity to local anesthetics
˗ Pregnant women
˗ Nursing women
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E.5 End points |
E.5.1 | Primary end point(s) |
Speech discrimination score in noise at Day 14 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At day 14 after the first intratympanic injection of Latanopros/placebo |
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E.5.2 | Secondary end point(s) |
˗ Speech discrimination score in noise at Day 28, Day 42, Day 56 and Day 84
˗ Pure tone audiometry at 250Hz, 500Hz, 1kHz, 2 kHz, 3kHz, 4kHz, 6kHz, and 8 kHz
˗ Tinnitus (subjective assessment by THI)
˗ Hearing (subjective assessment by Likert scale)
˗ Tinnitus (subjective assessment by Likert scale)
˗ Vertigo (subjective assessment by Likert scale)
˗ Number of vertigo attacks lasting ≥ 20 minutes (as recorded by patient)
˗ Number of drop attacks (as recorded by patient)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At day 28, day 42, day 56 and day 84 after the first intratympanic injection of Latanoprost/placebo. |
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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 | Yes |
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 | No |
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) | Yes |
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 | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 12 |
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 | No |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |