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

Phase 2

Completed

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 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 & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
AUT00063 (600 mg capsules)	AUT00063	3 capsules of 200 mg of the investigational drug AUT00063, to take orally once daily with food for 4 weeks
(AUT00063 placebo capsules)	Placebo	3 capsules of placebo, to take orally once daily with food for 4 weeks

Primary Outcome Measures

Name	Time	Method
Change in Hearing Loss After 4 Weeks of Treatment	28 days	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).

Secondary Outcome Measures

Name	Time	Method
Analysis of Change From Baseline in Adaptive Test of Temporal Resolution (ATTR) on End-Point Visit Day 28	28 days	Final Average GDT Within-Channel at Day 28: Change from Baseline; FAS Population
To Further Investigate the Safety and Tolerability Profile of Repeat Administration of AUT00063 by Assessing Vital Signs, Physical Examination, Laboratory Exams and ECG	42 Days	Number of Subjects With At Least One Treatment Emergent Adverse Event
Pharmacokinetic of AUT00063, Plasma Levels	28 Days	Exposure of AUT00063 ng/ml, in plasma levels at Day 28

Locations (13): The University of Mississippi Medical Center
🇺🇸
Jackson, Mississippi, United States
QPS MRA (Miami Research Associates)
🇺🇸
Miami, Florida, United States
Sacramento ENT
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Sacramento, California, United States
Mayo Clinic
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Rochester, Minnesota, United States
Piedmont Ear, Nose, & Throat Associates
🇺🇸
Winston-Salem, North Carolina, United States
Vanderbilt University Medical Center
🇺🇸
Nashville, Tennessee, United States
Colorado ENT and Allergy
🇺🇸
Colorado Springs, Colorado, United States
ENT Associates of South Florida
🇺🇸
Boca Raton, Florida, United States
University of Louisville
🇺🇸
Louisville, Kentucky, United States
Long Island Jewish Medical Center
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New Hyde Park, New York, United States
PMG Research Inc.
🇺🇸
Wilmington, North Carolina, United States
University of South Florida
🇺🇸
Tampa, Florida, United States
Jean Brown Research
🇺🇸
Murray, Utah, United States