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

Primary Purpose

Age-Related Hearing Loss

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AUT00063
Placebo
Sponsored by
Autifony Therapeutics Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-Related Hearing Loss focused on measuring hearing loss, speech-in-noise

Eligibility Criteria

50 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • 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

Sites / Locations

  • Sacramento ENT
  • Colorado ENT and Allergy
  • ENT Associates of South Florida
  • QPS MRA (Miami Research Associates)
  • University of South Florida
  • University of Louisville
  • Mayo Clinic
  • The University of Mississippi Medical Center
  • Long Island Jewish Medical Center
  • PMG Research Inc.
  • Piedmont Ear, Nose, & Throat Associates
  • Vanderbilt University Medical Center
  • Jean Brown Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

AUT00063 (600 mg capsules)

(AUT00063 placebo capsules)

Arm Description

3 capsules of 200 mg of the investigational drug AUT00063, to take orally once daily with food for 4 weeks

3 capsules of placebo, to take orally once daily with food for 4 weeks

Outcomes

Primary Outcome Measures

Change in Hearing Loss After 4 Weeks of Treatment
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

Analysis of Change From Baseline in Adaptive Test of Temporal Resolution (ATTR) on End-Point Visit Day 28
Final Average GDT Across-Channel at Day 28: Change from Baseline; FAS Population
Analysis of Change From Baseline in Adaptive Test of Temporal Resolution (ATTR) on End-Point Visit Day 28
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
Number of Subjects With At Least One Treatment Emergent Adverse Event
Pharmacokinetic of AUT00063, Plasma Levels
Exposure of AUT00063 ng/ml, in plasma levels at Day 28

Full Information

First Posted
January 19, 2015
Last Updated
August 8, 2018
Sponsor
Autifony Therapeutics Limited
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1. Study Identification

Unique Protocol Identification Number
NCT02345031
Brief Title
Efficacy and Safety of AUT00063 Versus Placebo in Age-Related Hearing Loss
Acronym
CLARITY-1
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

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Autifony Therapeutics Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Hearing Loss
Keywords
hearing loss, speech-in-noise

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AUT00063 (600 mg capsules)
Arm Type
Active Comparator
Arm Description
3 capsules of 200 mg of the investigational drug AUT00063, to take orally once daily with food for 4 weeks
Arm Title
(AUT00063 placebo capsules)
Arm Type
Placebo Comparator
Arm Description
3 capsules of placebo, to take orally once daily with food for 4 weeks
Intervention Type
Drug
Intervention Name(s)
AUT00063
Other Intervention Name(s)
Experimental
Intervention Description
600 mg, orally, once a day, for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Comparator
Intervention Description
orally, once a day, for 4 weeks
Primary Outcome Measure Information:
Title
Change in Hearing Loss After 4 Weeks of Treatment
Description
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).
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Analysis of Change From Baseline in Adaptive Test of Temporal Resolution (ATTR) on End-Point Visit Day 28
Description
Final Average GDT Across-Channel at Day 28: Change from Baseline; FAS Population
Time Frame
28 days
Title
Analysis of Change From Baseline in Adaptive Test of Temporal Resolution (ATTR) on End-Point Visit Day 28
Description
Final Average GDT Within-Channel at Day 28: Change from Baseline; FAS Population
Time Frame
28 days
Title
To Further Investigate the Safety and Tolerability Profile of Repeat Administration of AUT00063 by Assessing Vital Signs, Physical Examination, Laboratory Exams and ECG
Description
Number of Subjects With At Least One Treatment Emergent Adverse Event
Time Frame
42 Days
Title
Pharmacokinetic of AUT00063, Plasma Levels
Description
Exposure of AUT00063 ng/ml, in plasma levels at Day 28
Time Frame
28 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Frisina, PhD
Organizational Affiliation
Director Global Center for Hearing and Speech Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sacramento ENT
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
Colorado ENT and Allergy
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
ENT Associates of South Florida
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33487
Country
United States
Facility Name
QPS MRA (Miami Research Associates)
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33620
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55095
Country
United States
Facility Name
The University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
PMG Research Inc.
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Piedmont Ear, Nose, & Throat Associates
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Jean Brown Research
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States

12. IPD Sharing Statement

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

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