Phase 2 N=78 Randomized Quadruple-blind Treatment

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

Age-Related Hearing Loss

Bottom Line

View on ClinicalTrials.gov: NCT02345031 ↗

Enrolled (actual)

Serious AEs

1.3%

Results posted

Sep 2017

Primary outcome: Primary: Change in Hearing Loss After 4 Weeks of Treatment — -1.114; -1.914 decibels (dB)

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: AUT00063 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Autifony Therapeutics Limited
Primary completion: May 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Hearing Loss After 4 Weeks of Treatment	-1.114; -1.914	—
SECONDARY Analysis of Change From Baseline in Adaptive Test of Temporal Resolution (ATTR) on End-Point Visit Day 28	4.452; 5.526	—
SECONDARY Analysis of Change From Baseline in Adaptive Test of Temporal Resolution (ATTR) on End-Point Visit Day 28	4.452; 5.526	—
SECONDARY To Further Investigate the Safety and Tolerability Profile of Repeat Administration of AUT00063 by Assessing Vital Signs, Physical Examination, Laboratory Exams and ECG	23; 24	—
SECONDARY Pharmacokinetic of AUT00063, Plasma Levels	3470.61; 0	—

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02345031). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.