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

Tinnitus Clinical Trial

— TACTT1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01270282
• Other study ID #: AM-101-CL-10-02
• Secondary ID: AM-101-CL-10-02
• Status: Completed
• Phase: Phase 2
• First received: December 30, 2010
• Last updated: January 13, 2015
• Start date: February 2011
• Est. completion date: May 2013

Study information

• Verified date: January 2015
• Source: Auris Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinnitus

Intervention

Drug:
• AM-101 0.81 mg/mL

• Placebo

Locations

Country	Name	City	State
Belgium	UZ Antwerp, Department of ENT	Edegem
Belgium	Gent University Hospital, Department of ENT	Gent
Belgium	Virga Jesseziekenhuis Hasselt	Hasselt
Germany	HNO Praxis im Schlosscarree	Braunschweig
Germany	Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie	Frankfurt am Main
Germany	HNO Gemeinschaftspraxis	Heidelberg
Germany	HNO Praxis	Köln
Germany	Bundeswehrkrankenhaus Ulm	Ulm
Poland	NZOZ Laryngologii Wojewodzki Szpital Specjalistyczny	Rzeszów
Poland	NZOZ Centrum Medyczne LiMED	Tarnowskie Góry
Poland	Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie	Warsaw
United States	Summit Medical Group	Berkeley Heights	New Jersey
United States	University of Florida College of Medicine	Gainsville	Florida
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Advanced ENT & Allergy	Louisville	Kentucky
United States	PMG Research of Winston-Salem	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Auris Medical, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in tinnitus loudness by magnitude estimation from Baseline to 90 days following the last injection		90 or 104 days	No
Secondary	Standard audiological evaluations	Pure tone audiometry, tympanometry, otoscopy, tinnitus loudness match	90 or 104 days	Yes
Secondary	Questionnaires evaluating the impact of tinnitus	Patient global impression of change scale, subjective tinnitus annoyance and loudness, tinnitus handicap questionaire	90 or 104 days	No
Secondary	Pharmacokinetic measures		3 or 14 days	Yes