Clinical trial NCT02345031: Efficacy and Safety of AUT00063 Versus Placebo in Age-Related Hearing Loss
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]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Age-Related Hearing Loss
Keywords: hearing loss
speech-in-noise
Lead sponsor: Autifony Therapeutics Limited
Sponsor class: INDUSTRY
First posted: 2015-01-26
Enrollment: 78
Sex: ALL
Minimum age (years): 50
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Hearing Loss After 4 Weeks of Treatment
timeFrame: 28 days
Secondary outcomes:
measure: Analysis of Change From Baseline in Adaptive Test of Temporal Resolution (ATTR) on End-Point Visit Day 28
timeFrame: 28 days
measure: Analysis of Change From Baseline in Adaptive Test of Temporal Resolution (ATTR) on End-Point Visit Day 28
timeFrame: 28 days
measure: To Further Investigate the Safety and Tolerability Profile of Repeat Administration of AUT00063 by Assessing Vital Signs, Physical Examination, Laboratory Exams and ECG
timeFrame: 42 Days
measure: Pharmacokinetic of AUT00063, Plasma Levels
timeFrame: 28 Days
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Sacramento ENT
state: California
city: Colorado Springs
country: United States
facility: Colorado ENT and Allergy
state: Colorado
city: Boca Raton
country: United States
facility: ENT Associates of South Florida
state: Florida
city: Miami
country: United States
facility: QPS MRA (Miami Research Associates)
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Jackson
country: United States
facility: The University of Mississippi Medical Center
state: Mississippi
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: Wilmington
country: United States
facility: PMG Research Inc.
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Ear, Nose, & Throat Associates
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Murray
country: United States
facility: Jean Brown Research
state: Utah
Study officials:
affiliation: Director Global Center for Hearing and Speech Research
name: Robert Frisina, PhD
role: PRINCIPAL_INVESTIGATOR
References: