E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute inner ear tinnitus following acute acoustic trauma or sudden deafness. |
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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 | 10043882 |
E.1.2 | Term | Tinnitus |
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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 |
The primary objective of the study is the evaluation of the therapeutic benefit of three repeated dose intratympanic AM-101 injections in comparison to placebo in the treatment of acute inner ear tinnitus following acute acoustic trauma or sudden deafness. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of the study are (a) safety and local tolerance of three repeated intratympanic AM-101 injections and (b) identification of the optimal dose of AM-101 in the treatment of acute inner ear tinnitus following acute acoustic trauma or sudden deafness. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• • Persistent tinnitus following acute acoustic trauma or sudden deafness with onset less than three months ago (i.e. acute tinnitus) • Tinnitus provoking incident of acute acoustic trauma or sudden deafness is documented by audiogram or medical report • Minimum Masking Level (MML) of at least 5 dB SL • Age ≥ 18 years and ≤ 65 years • Negative pregnancy test for women of childbearing potential • Willing and able to attend the on-study visits • Written informed consent before participation in the study
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E.4 | Principal exclusion criteria |
• Tinnitus that is not completely maskable • Fluctuating tinnitus • Intermittent tinnitus • Meniere’s Disease • Acute or chronic otitis media or otitis externa • Any ongoing therapy known as potentially tinnitus-inducing (e.g. aminoglycosides, cisplatin, loop diuretics, high doses of aspirin, quinine etc.) • Any drug-based therapy for inner ear hearing loss that is ongoing or was performed in the past 2 weeks, e.g. prednisolone, dexamethasone, pentoxyfilline, betahistine, diazepam, carbamazepine, sodium valproate and antidepressants • Concomitant use of any other NMDA receptor antagonist (e.g. memantine, dextromethorphan, ifenprodil) • Any ongoing or planned concomitant medication for the treatment of tinnitus until 90 days after study drug application • History or presence of drug abuse or alcoholism • Any clinically relevant respiratory, cardiovascular, neurological (except vertigo), or psychiatric disorder • Known hypersensitivity, allergy or intolerance to the study medication or any history of severe abnormal drug reaction • Women who are breast-feeding, pregnant or who plan a pregnancy during the trial • Women of childbearing potential who declare being unwilling or unable to practice contraception such as hormonal contraceptives, sexual abstinence or intercourse with a vasectomised partner • Concurrent participation in another clinical trial with an investigational drug or participation in another clinical trial with an investigational drug within 30 days prior to study entry
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E.5 End points |
E.5.1 | Primary end point(s) |
The change in the minimum masking level (MML) in dB from Baseline to D90. |
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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 | Yes |
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) | 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 | 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.8.3 |
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 | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
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 | Yes |
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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Randomisation and patient enrolment will be stopped, if based on a review of safety and tolerability data by the Safety Officer and after joint consultation between the Safety Officer and the Co-ordinating Investigators, further treatments are deemed not acceptable. |
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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 | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 3 |