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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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]

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

Detailed Summary:

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.


Sponsor: Autifony Therapeutics Limited

Current Primary Outcome: Change in hearing loss after 4 weeks of treatment [ Time Frame: 28 days ]

To compare the change from baseline (Day 1 to Day 28) between AUT00063 and placebo, on a speech-in-noise deficit


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in parameters of hearing performance from baseline to day 28 [ Time Frame: 28 days ]
    Changes in hearing tests
  • To further investigate the safety and tolerability profile of repeat administration of AUT00063 by assessing vital signs, physical examination, laboratory exams and ECG [ Time Frame: 42 days ]
    To investigate the safety and tolerability of AUT00063 by assessing vital signs, physical examination, laboratory exams and ECG
  • Pharmacokinetic of AUT00063, plasma levels [ Time Frame: 28 days ]
    Exposure of AUT00063 ng/ml, in plasma levels at Day 28


Original Secondary Outcome: Same as current

Information By: Autifony Therapeutics Limited

Dates:
Date Received: January 19, 2015
Date Started: January 2015
Date Completion:
Last Updated: September 14, 2016
Last Verified: September 2016