NCT02345031

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Autifony Therapeutics Limited · Industry
• Sex: All
• Age: 50 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Age-Related Hearing Loss

Interventions

Type	Name	Description
DRUG	AUT00063	600 mg, orally, once a day, for 4 weeks
DRUG	Placebo	orally, once a day, for 4 weeks

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-05-01
• Completion: 2016-06-01
• First posted: 2015-01-26
• Last updated: 2018-08-09
• Results posted: 2017-09-19

Locations

13 sites across 1 country: United States