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

PHASE3TerminatedINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

June 30, 2016

Primary Completion Date

February 28, 2018

Study Completion Date

February 28, 2018

Conditions
Hearing Loss, Idiopathic Sudden Sensorineural
Interventions
DRUG

AM-111 0.4 mg/ml

AM-111 0.4 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia

DRUG

AM-111 0.8 mg/ml

AM-111 0.8 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia

OTHER

Placebo

Placebo gel is administered with a single dose into the affected ear after topical anesthesia

Trial Locations (51)

3722

Seoul

6591

Seoul

8308

Seoul

10032

New York

12553

New Windsor

14618

Rochester

19083

Havertown

19107

Philadelphia

23507

Norfolk

28105

Matthews

28210

Charlotte

29078

Lugoff

29118

Orangeburg

29425

Charleston

33133

Miami

33176

Miami

33487

Boca Raton

34747

Celebration

34952

Port Saint Lucie

40207

Louisville

48374

Novi

50312

Des Moines

60657

Chicago

61469

Seoul

65212

Columbia

66160

Kansas City

78234

Fort Sam Houston

80045

Aurora

84102

Salt Lake City

84790

St. George

92025

Escondido

93720

Fresno

35294-0012

Birmingham

92037-1214

La Jolla

06519

New Haven

33426-6398

Boynton Beach

03756

Lebanon

11042-1121

New Hyde Park

10601-4413

White Plains

27103-1522

Winston-Salem

37232-8605

Nashville

98431-1100

Tacoma

Unknown

Kelowna

Penticton

Markham

Seongnam-si

Suwon

Incheon

Gwangju

Pusan

Seoul

Sponsors
All Listed Sponsors
lead

Auris Medical, Inc.

INDUSTRY

NCT02809118 - Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment | Biotech Hunter | Biotech Hunter