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Efficacy and Safety of AUT00063 Versus Placebo in Age-Related Hearing Loss (CLARITY-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02345031
Recruitment Status : Completed
First Posted : January 26, 2015
Results First Posted : September 19, 2017
Last Update Posted : August 9, 2018
Information provided by (Responsible Party):
Autifony Therapeutics Limited

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

Condition or disease Intervention/treatment Phase
Age-Related Hearing Loss Drug: AUT00063 Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: AUT00063 (600 mg capsules)
3 capsules of 200 mg of the investigational drug AUT00063, to take orally once daily with food for 4 weeks
Drug: AUT00063
600 mg, orally, once a day, for 4 weeks
Other Name: Experimental

Placebo Comparator: (AUT00063 placebo capsules)
3 capsules of placebo, to take orally once daily with food for 4 weeks
Drug: Placebo
orally, once a day, for 4 weeks
Other Name: Comparator

Primary Outcome Measures :
  1. Change in Hearing Loss After 4 Weeks of Treatment [ Time Frame: 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 :
  1. Analysis of Change From Baseline in Adaptive Test of Temporal Resolution (ATTR) on End-Point Visit Day 28 [ Time Frame: 28 days ]
    Final Average GDT Across-Channel at Day 28: Change from Baseline; FAS Population

  2. Analysis of Change From Baseline in Adaptive Test of Temporal Resolution (ATTR) on End-Point Visit Day 28 [ Time Frame: 28 days ]
    Final Average GDT Within-Channel at Day 28: Change from Baseline; FAS Population

  3. To Further Investigate the Safety and Tolerability Profile of Repeat Administration of AUT00063 by Assessing Vital Signs, Physical Examination, Laboratory Exams and ECG [ Time Frame: 42 Days ]
    Number of Subjects With At Least One Treatment Emergent Adverse Event

  4. Pharmacokinetic of AUT00063, Plasma Levels [ Time Frame: 28 Days ]
    Exposure of AUT00063 ng/ml, in plasma levels at Day 28

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02345031

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United States, California
Sacramento ENT
Sacramento, California, United States, 95815
United States, Colorado
Colorado ENT and Allergy
Colorado Springs, Colorado, United States, 80909
United States, Florida
ENT Associates of South Florida
Boca Raton, Florida, United States, 33487
QPS MRA (Miami Research Associates)
Miami, Florida, United States, 33143
University of South Florida
Tampa, Florida, United States, 33620
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55095
United States, Mississippi
The University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, New York
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11042
United States, North Carolina
PMG Research Inc.
Wilmington, North Carolina, United States, 28401
Piedmont Ear, Nose, & Throat Associates
Winston-Salem, North Carolina, United States, 27103
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Utah
Jean Brown Research
Murray, Utah, United States, 84107
Sponsors and Collaborators
Autifony Therapeutics Limited
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Principal Investigator: Robert Frisina, PhD Director Global Center for Hearing and Speech Research
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Responsible Party: Autifony Therapeutics Limited Identifier: NCT02345031    
Other Study ID Numbers: AUT022063
First Posted: January 26, 2015    Key Record Dates
Results First Posted: September 19, 2017
Last Update Posted: August 9, 2018
Last Verified: August 2018
Keywords provided by Autifony Therapeutics Limited:
hearing loss
Additional relevant MeSH terms:
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Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Hearing Loss, Sensorineural