Comparison of Single Versus Repeat Doses of AM-101 in the Treatment of Acute Inner Ear Tinnitus (TACTT1)

Auris Medical

Status and phase: Completed; Phase 2

Conditions: Tinnitus

Treatments: Drug: AM-101 0.81 mg/mL; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01270282

AM-101-CL-10-02 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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82 participants in 2 patient groups, including a placebo group

AM-101 0.81 mg/mL

Experimental group

Description:

Gel for injection; single or triple injection

Treatment:

Drug: AM-101 0.81 mg/mL

Placebo

Placebo Comparator group

Description:

Gel for injection; single or triple injection

Treatment:

Drug: Placebo