Administration of a single dose or of three doses of AM-101to patients with Tinnitus (Ringing in the Ears) and comparision of both doses.

Phase 1

• Conditions: Acute inner ear tinnitus following acute acustic trauma, acute otitis media, middle ear surgery, or inner ear barotrauma; MedDRA version: 14.1Level: PTClassification code 10043882Term: TinnitusSystem Organ Class: 10013993 - Ear and labyrinth disorders; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2011-005384-24-BE
• Lead Sponsor: Auris Medical AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-29
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

A subject will be eligible for inclusion in this study if all of the following criteria apply:

1. Persistent tinnitus (unilateral or bilateral) following acute acoustic trauma, acute otitis media, middle ear surgery or inner ear barotraumas with onset up to three months ago (i.e. acute tinnitus), as documented by medical report.
2. Age = 18 years and = 65 years.
3. Negative pregnancy test for women of childbearing potential.
4. Willing and able to attend the study visits.
5.Able to read and understand study documents, and investigator instructions.
6. Signed IEC (Independent Ethics Committee)-approved Informed Consent Form.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 72
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A subject will not be eligible for inclusion in this study if any of the following criteria apply:

1. Fluctuating Tinnitus.
2. Intermittent Tinnitus.
3. Menière's Disease.
4. Ongoing acute or chronic Otitis media or Otitis externa.
5. Any drug-based therapy for Otitis media that is ongoing or was performed in the past 2 weeks.
6. Any therapy known as potentially Tinnitus-inducing (e.g. aminoglycosides, cisplatin, loop diuretics, high doses of aspirin [> 5 adult doses/day] or quinine) in the past 2 weeks or that is ongoing or planned for the study duration.
7. 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, car-bamazepine, sodium valproate and antidepressants.
8. Use of any other NMDA receptor antagonist (e.g. memantine, dextromethorphan) in the past 2 weeks, or that is ongoing, or that is planned for the study duration.
9. Any ongoing or planned treatment of Tinnitus for the study duration.
10. History within the past two years or presence of drug abuse or alcoholism.
11. Any clinically relevant respiratory, cardiovascular, neurological (except vertigo), or psychiatric disorder, as determined by the Investigator.
12. Known hypersensitivity, allergy or intolerance to the study medication or any history of severe, abnormal drug reaction.
13. Women who are breast-feeding, pregnant or who are planning to become pregnant during the trial.
14. Women of childbearing potential who are unwilling or unable to practice contraception, such as hormonal contraceptives, double barrier, sexual abstinence or intercourse with a partner who has been vasectomised for at least three months.
15. Concurrent participation in another clinical trial or participation in another clinical trial within 30 days prior to study entry.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified