Efficacy and Safety of AM-111 as Sudden Hearing Loss Treatment.

Phase 1

Conditions: Idiopathic sudden sensorineural hearing loss.
MedDRA version: 20.0Level: PTClassification code 10061373Term: Sudden hearing lossSystem Organ Class: 10013993 - Ear and labyrinth disorders
Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

Registration Number: EUCTR2016-005166-58-CZ

Lead Sponsor: Auris Medical Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

1. Unilateral ISSNHL with onset within 72 hours prior to study treatment;
2. Mean hearing threshold of equal to or worse than (=) 60 dB averaged across those 3 contiguous air conduction audiometric pure tone frequencies that show the highest mean hearing loss compared with the unaffected contralateral ear or, in case of history of asymmetric hearing, corresponding values from a pre-existing audiogram for the affected ear not older than 2 years prior to the ISSNHL incident (defined as pure tone average”, PTA);*
3. Mean hearing loss of equal to or worse than (=) 40 dB averaged across the air conduction thresholds at the pure tone average fre-quencies compared with the unaffected contralateral ear or, in case of history of asymmetric hearing, corresponding values from a pre-existing audiogram for the affected ear not older than 2 years prior to the ISSNHL incident;*
4. Age = 18 years on the day of screening;
5. Negative urine pregnancy test for women of childbearing potential. Women are not considered to be of childbearing potential if they meet one of the following criteria:
a. They have had a hysterectomy or tubal ligation at least one cycle prior to signing the Informed Consent Form (ICF) or
b. They are post-menopausal, with at least one year since their last menstrual period;
6. Willing and able to attend the trial visits;
7. Able to read and understand trial documents and follow Investigator and trial personnel instructions during visits, including audiology measurements;
8. Willing and able to use adequate hearing protection and to refrain from engaging in activities or work involving loud noise exposure where sufficient hearing protection is not possible or ensured for the duration of their participation in this study;
9. Willing and able to protect the ear canal and middle ear from water exposure for as long as the tympanic membrane is not fully closed;
10. Signed Institutional Review Board (IRB) / Independent Ethics Committee (IEC) approved ICF.
* In subjects assessed within the first 24 hours from ISSNHL onset, inclusion criteria 2 and 3 have to be confirmed by a second measure that is conducted, at the earliest, 24 hours after the onset of ISSNHL. This confirmatory assessment will serve as baseline value.
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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

1. Bilateral ISSNHL;
2. Acute hearing loss from noise trauma, barotrauma or head trauma;
3. Air-bone gap greater than 20 dB at the average of 3 contiguous test frequencies below 4 kHz, when the air-bone gap is measurable;
4. History of autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops or Menière’s disease in either ear;
5. History of chronic inflammatory or suppurative ear disease or cholesteatoma in the affected ear;
6. Current evidence or history of acoustic neuroma or other retrocochlear damage in the affected ear;
7. History of otosclerosis in the affected ear;
8. Suspected perilymph fistula or membrane rupture in the affected ear;
9. Congenital hearing loss;
10. History of ISSNHL in the past 2 years;
11. Otitis media or otitis externa that is ongoing or ended within 7 days prior to study treatment;
12. Radiation therapy in the head and neck area within the past 5 years;
13. Abnormality of the tympanic membrane in the affected ear that would preclude intratympanic administration;
14. Any pre-treatment or ongoing treatment for ISSNHL-related hearing loss or tinnitus (except for oral corticosteroid background therapy that was started within 36 hours prior to randomization);
15. Any other planned pharmacological or non-pharmacological treatment for hearing loss or tinnitus for the duration of the trial;
16. Any therapy known as ototoxic (e.g. aminoglycosides [systemic or ototopical with middle ear exposure], cisplatin, loop diuretics, quinine etc.) in the 3 months prior to treatment visit;
17. History within the past 2 years or presence of drug abuse or alcoholism;
18. Subjects with diagnosed anxiety disorders, psychosis, depression, schizophrenia, attempted suicide or other significant psychiatric conditions that can impact their ability to cooperate and comply with the study protocol;
19. Subjects who have answered yes” to Suicidal Ideation question 4 or 5 of the C-SSRS;
20. Any clinically relevant autoimmune, respiratory, cardiovascular, neurological disorder (except vertigo or tinnitus) or other abnormality that in the opinion of the Investigator may pose a safety risk to a subject in this study, which may confound efficacy or safety assessment, or may interfere with study participation;
21. Known HIV, hepatitis B or hepatitis C infection, or symptomatic herpes zoster infection;
22. Women who are breast-feeding, pregnant or who are planning to become pregnant during the study;
23. Women of childbearing potential who are unwilling or unable to use an effective method of avoiding pregnancy from screening until the end of the study (FUV4). Effective methods of avoiding pregnancy are contraceptive methods with a Pearl index of less than 1 when used consistently and correctly (including implantable, injectable, oral and transdermal contraceptives, intrauterine devices, diaphragm with spermicide, male or female condoms with spermicide, or cervical cap, or a sterile sexual partner, or being abstinent);
24. Concurrent participation in another clinical study or participation in another clinical study within 30 days prior to randomization (TV).