Comparison of Single Versus Repeat Doses of AM-101 in the Treatment of Acute Inner Ear Tinnitus

Phase 2

Completed

• Conditions: Tinnitus
• Interventions: Drug: AM-101 0.81 mg/mL; Drug: Placebo

• Registration Number: NCT01270282
• Lead Sponsor: Auris Medical, Inc.

Brief Summary

The purpose of the study is to evaluate the therapeutic benefit and safety of intratympanic AM-101 injections in comparison to placebo in the treatment of persistent acute inner ear tinnitus.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-12-30
• Study First Submitted QC: 2011-01-04
• Study First Posted: 2011-01-05
• Study Start: 2011-02
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Disposition First Submitted: 2014-06-24
• Status Verified: 2015-01
• Disposition First Submitted QC: 2015-01-13
• Last Update Submitted: 2015-01-13
• Disposition First Posted: 2015-01-26
• Last Update Posted: 2015-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• Tinnitus following acute acoustic trauma, acute otitis media, middle ear surgery or inner ear barotrauma; with onset less than three months ago.

Exclusion Criteria

• Tinnitus that is not completely maskable
• Fluctuating tinnitus
• Intermittent tinnitus
• Meniere's Disease
• Ongoing acute or chronic otitis media or otitis externa.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AM-101 0.81 mg/mL	AM-101 0.81 mg/mL	Gel for injection; single or triple injection
Placebo	Placebo	Gel for injection; single or triple injection

Primary Outcome Measures

Name	Time	Method
The change in tinnitus loudness by magnitude estimation from Baseline to 90 days following the last injection	90 or 104 days

Secondary Outcome Measures

Name	Time	Method
Standard audiological evaluations	90 or 104 days	Pure tone audiometry, tympanometry, otoscopy, tinnitus loudness match
Questionnaires evaluating the impact of tinnitus	90 or 104 days	Patient global impression of change scale, subjective tinnitus annoyance and loudness, tinnitus handicap questionaire
Pharmacokinetic measures	3 or 14 days

Trial Locations

Locations (16)

Advanced ENT & Allergy; 🇺🇸 Louisville, Kentucky, United States

PMG Research of Winston-Salem; 🇺🇸 Winston-Salem, North Carolina, United States

HNO Gemeinschaftspraxis; 🇩🇪 Heidelberg, Germany

NZOZ Laryngologii Wojewodzki Szpital Specjalistyczny; 🇵🇱 Rzeszów, Poland

Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie; 🇵🇱 Warsaw, Poland

University of Florida College of Medicine; 🇺🇸 Gainsville, Florida, United States

Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie; 🇩🇪 Frankfurt am Main, Germany

Summit Medical Group; 🇺🇸 Berkeley Heights, New Jersey, United States

HNO Praxis im Schlosscarree; 🇩🇪 Braunschweig, Germany

UZ Antwerp, Department of ENT; 🇧🇪 Edegem, Belgium

Gent University Hospital, Department of ENT; 🇧🇪 Gent, Belgium

Virga Jesseziekenhuis Hasselt; 🇧🇪 Hasselt, Belgium

HNO Praxis; 🇩🇪 Köln, Germany

Bundeswehrkrankenhaus Ulm; 🇩🇪 Ulm, Germany

NZOZ Centrum Medyczne LiMED; 🇵🇱 Tarnowskie Góry, Poland

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States