NCT00860808

Efficacy of AM 101 in Patients With Acute Inner Ear Tinnitus

Efficacy of AM 101 in Patients With Acute Inner Ear Tinnitus: A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled, Multiple Dose, Group Comparison Phase II Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 248 (actual)
• Sponsor: Auris Medical AG · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is the evaluation of the therapeutic benefit of intratympanic AM 101 injections in comparison to placebo in the treatment of persistent acute inner ear tinnitus following acute sensorineural hearing loss.

Detailed description

Tinnitus may seriously impact the ability to sleep, relax, or to concentrate, or lead to tiredness, irritation, nervousness, despair, frustration, or depression, thus severely impacting the quality of life and health of the affected person. To date, there exists no pharmaceutical treatment for persisting tinnitus. Non-clinical studies with AM-101 have shown that the inhibition of cochlear NMDA receptors is successful in suppressing tinnitus without affecting normal glutamate neurotransmission respectively hearing function. In particular, it could be demonstrated that local administration of AM-101 in a single dose resulted in a complete suppression of tinnitus induced by acute acoustic trauma without any relapse thereafter.

Conditions

• Tinnitus

Interventions

Type	Name	Description
DRUG	AM-101	Triple intratympanic injection (one on each day 1, 2, and 3)

Timeline

• Start date: 2009-03-01
• Primary completion: 2011-05-01
• Completion: 2011-08-01
• First posted: 2009-03-12
• Last updated: 2013-02-13

Locations

1 site across 1 country: Germany