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



Status:Completed
Conditions:Other Indications, Other Indications
Therapuetic Areas:Other
Healthy:No
Age Range:50 - 89
Updated:8/11/2018
Start Date:January 2015
End Date:June 2016

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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]

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

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.

- 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
We found this trial at
13
sites
2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Jackson, MS
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
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Tampa, FL
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Boca Raton, Florida 33487
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Colorado Springs, Colorado 80909
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
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Louisville, KY
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Miami, FL
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Murray, Utah 84107
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Murray, UT
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270-05 76th Ave
New Hyde Park, New York 11040
(718) 470-7480
Long Island Jewish Medical Center Serving North Shore LIJ Health System employees and their families....
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New Hyde Park, NY
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Rochester, Minnesota 55905
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Rochester, MN
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Sacramento, California 95815
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Sacramento, CA
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Wilmington, North Carolina 28401
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Wilmington, NC
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Winston-Salem, North Carolina 27103
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Winston-Salem, NC
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