Efficacy and Safety of AUT00063 Versus Placebo in Age-Related Hearing Loss — CLARITY-1  

Age-Related Hearing Loss Clinical Trial

Official title: A Balanced, Randomized, Placebo-Controlled, Double-Blind Study of the Efficacy and Safety of AUT00063 Versus Placebo in Age-Related Hearing Loss [CLARITY-1 Study]

Status Completed

Clinical Trial Summary

This study aims to demonstrate that the investigational drug AUT00063 is effective and safe in the treatment of age-related hearing loss.

Clinical Trial Description

Reduced activity at certain sites in the brain (called "voltage-gated potassium channels") has been linked to hearing problems, like age-related loss of hearing or tinnitus (a 'ringing' or buzzing noise in the ears).

AUT00063 is an experimental new medicine that enhances the action of these specific channels and so may treat the brain component of these hearing problems.

The main purpose of this study is to try to demonstrate an improvement in a speech-in-noise deficit after 4 weeks of treatment with the study drug versus the placebo (dummy drug which does not contain the drug). Subjects will undergo a safety follow-up after the treatment period.

Safety and efficacy will be determined by looking at a number of assessments (physical examinations, blood sampling, hearing assessments, questionnaires, etc.).

The amount of drug in the blood will also be measured. It is expected that around 70 people (at least 35 in each arm) with age-related hearing loss may take part in the study. The study participants will be recruited at around 13 sites in the USA. ;

Related Conditions & MeSH terms

• Age-Related Hearing Loss
• Deafness
• Hearing Loss
• Presbycusis

• NCT number: NCT02345031
• Study type: Interventional
• Source: Autifony Therapeutics Limited
• Status: Completed
• Phase: Phase 2
• Start date: January 2015
• Completion date: June 2016