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

Age-Related Hearing Loss Clinical Trial

— CLARITY-1  

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]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02345031
• Other study ID #: AUT022063
• Status: Completed
• Phase: Phase 2
• Start date: January 2015
• Est. completion date: June 2016

Study information

• Verified date: August 2018
• Source: Autifony Therapeutics Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 89 Years

Eligibility

• Be between ages 50-89 years old

• American-English speaking

• Have difficulty hearing speech in a noisy environment

• No recent history of middle ear disease

• No severe insomnia, major depressive disorders, severe anxiety or post-traumatic stress disorder

• Not a current or previous user of hearing aids. You are eligible if you were noncompliant and stopped wearing a hearing aid device >6 months earlier for intermittent use or >3 years if you were a full-time consistent user of hearing aid devices

• Not be dependent on alcohol or drugs

• Have not participated in another research study within 30-days

• If female, you must confirm to be non child bearing (post-menopausal for at least 12-months or surgically sterile)

• If male, you must confirm to use a barrier method (condom)

• Not be a professional musician

• No history of important cardiac, endocrine, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major disease deemed clinically significant by the study doctor

While you are in the study, you must:

• Follow the instructions you are given

• Come to the study centre for all visits with the study doctor or study staff

• Answer the telephone at the scheduled date and time for the 2 telephone calls

• Tell the study doctor or study staff about any changes in your health or the way you feel

• Tell the study doctor or study staff if you want to stop being in the study at any time

• Bring your Diary to each visit

• Not eat or drink anything containing Grapefruit beginning 7-days before Baseline visit (Visit 3, Day 1) until the end of the study

• Use sun screen if you plan to sunbathe

• Not use headphones or headsets at high volume

• Not use hearing aids or devices at any time during the study

Related Conditions & MeSH terms

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

Intervention

Drug:
• AUT00063
600 mg, orally, once a day, for 4 weeks
• Placebo
orally, once a day, for 4 weeks

Locations

Country	Name	City	State
United States	ENT Associates of South Florida	Boca Raton	Florida
United States	Colorado ENT and Allergy	Colorado Springs	Colorado
United States	The University of Mississippi Medical Center	Jackson	Mississippi
United States	University of Louisville	Louisville	Kentucky
United States	QPS MRA (Miami Research Associates)	Miami	Florida
United States	Jean Brown Research	Murray	Utah
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Long Island Jewish Medical Center	New Hyde Park	New York
United States	Mayo Clinic	Rochester	Minnesota
United States	Sacramento ENT	Sacramento	California
United States	University of South Florida	Tampa	Florida
United States	PMG Research Inc.	Wilmington	North Carolina
United States	Piedmont Ear, Nose, & Throat Associates	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Autifony Therapeutics Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hearing Loss After 4 Weeks of Treatment	To compare the change in hearing using the QuickSIN test (speech in noise performance) from baseline (Day 1 to Day 28) between AUT00063 and placebo. The QuickSIN test measures the level of signal compared to the noise that is required to achieve 50% recognition. The test is administered in a sound booth at 70-dB HL binaurally via insert-ear phones. Three lists are administered to each individual subject and the threshold or 50% signal-to-noise ratio (SNR) is calculated as the mean of the three lists completed. Each list consists of six sentences with five key words to be scored per sentence. The sentences are presented in four-talker babble noise. The sentences are presented at pre-recorded signal-to-noise ratios which decrease in 5-dB steps from 25 (very easy) to 0 (extremely difficult).	28 days
Secondary	Analysis of Change From Baseline in Adaptive Test of Temporal Resolution (ATTR) on End-Point Visit Day 28	Final Average GDT Across-Channel at Day 28: Change from Baseline; FAS Population	28 days
Secondary	Analysis of Change From Baseline in Adaptive Test of Temporal Resolution (ATTR) on End-Point Visit Day 28	Final Average GDT Within-Channel at Day 28: Change from Baseline; FAS Population	28 days
Secondary	To Further Investigate the Safety and Tolerability Profile of Repeat Administration of AUT00063 by Assessing Vital Signs, Physical Examination, Laboratory Exams and ECG	Number of Subjects With At Least One Treatment Emergent Adverse Event	42 Days
Secondary	Pharmacokinetic of AUT00063, Plasma Levels	Exposure of AUT00063 ng/ml, in plasma levels at Day 28	28 Days