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

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ClinicalTrials.gov Identifier: NCT02345031
Recruitment Status : Completed
First Posted : January 26, 2015
Results First Posted : September 19, 2017
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Autifony Therapeutics Limited

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Age-Related Hearing Loss
Interventions Drug: AUT00063
Drug: Placebo
Enrollment 78
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AUT00063 (600 mg Capsules) (AUT00063 Placebo Capsules)
Hide Arm/Group Description

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

AUT00063: 600 mg, orally, once a day, for 4 weeks

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

Placebo: orally, once a day, for 4 weeks

Period Title: Overall Study
Started 38 40
Completed 37 39
Not Completed 1 1
Arm/Group Title AUT00063 (600 mg Capsules) (AUT00063 Placebo Capsules) Total
Hide Arm/Group Description

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

AUT00063: 600 mg, orally, once a day, for 4 weeks

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

Placebo: orally, once a day, for 4 weeks

Total of all reporting groups
Overall Number of Baseline Participants 38 40 78
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 39 participants 76 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
  40.5%
13
  33.3%
28
  36.8%
>=65 years
22
  59.5%
26
  66.7%
48
  63.2%
[1]
Measure Analysis Population Description: Demographic data are listed from Full Analysis Set, excludes 2 subjects.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 39 participants 76 participants
Female
15
  40.5%
17
  43.6%
32
  42.1%
Male
22
  59.5%
22
  56.4%
44
  57.9%
[1]
Measure Analysis Population Description: Demographics data are listed from Full Analysis Set, excludes 2 subjects
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 37 participants 39 participants 76 participants
White/Caucasian
36
  97.3%
38
  97.4%
74
  97.4%
Black/African-American
1
   2.7%
1
   2.6%
2
   2.6%
[1]
Measure Analysis Population Description: Demographic data are listed from Full Analysis Set, excludes 2 subjects
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnicity Number Analyzed 37 participants 39 participants 76 participants
Hispanic Or Latino
1
   2.7%
0
   0.0%
1
   1.3%
Not Hispanic Or Latino
36
  97.3%
39
 100.0%
75
  98.7%
[1]
Measure Analysis Population Description: Demographic data are listed from Full Analysis Set, excludes 2 subjects
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 38 participants 40 participants 78 participants
38
 100.0%
40
 100.0%
78
 100.0%
QuickSIN SNR-50 Score (dB)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Decibels (dB)
Number Analyzed 37 participants 39 participants 76 participants
7.00  (1.963) 7.11  (1.991) 7.06  (1.965)
[1]
Measure Description: The QuickSIN test measures the level of signal compared to the noise that is required to achieve 50% recognition and were administered in a sound booth at 70-dB HL binaurally. It is reported in decibels (dB).
[2]
Measure Analysis Population Description: QuickSIN data are listed from Full Analysis set, excludes 2 subjects
1.Primary Outcome
Title Change in Hearing Loss After 4 Weeks of Treatment
Hide 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
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Hide Analysis Population Description
Full Analysis Set
Arm/Group Title AUT00063 (600 mg Capsules) (AUT00063 Placebo Capsules)
Hide Arm/Group Description:

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

AUT00063: 600 mg, orally, once a day, for 4 weeks

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

Placebo: orally, once a day, for 4 weeks

Overall Number of Participants Analyzed 37 39
Least Squares Mean (95% Confidence Interval)
Unit of Measure: decibels (dB)
-1.114
(-1.956 to -0.272)
-1.914
(-2.703 to -1.125)
2.Secondary Outcome
Title Analysis of Change From Baseline in Adaptive Test of Temporal Resolution (ATTR) on End-Point Visit Day 28
Hide Description Final Average GDT Across-Channel at Day 28: Change from Baseline; FAS Population
Time Frame 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS Population
Arm/Group Title AUT00063 (600 mg Capsules) (AUT00063 Placebo Capsules)
Hide Arm/Group Description:

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

AUT00063: 600 mg, orally, once a day, for 4 weeks

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

Placebo: orally, once a day, for 4 weeks

Overall Number of Participants Analyzed 35 37
Least Squares Mean (95% Confidence Interval)
Unit of Measure: ms
-2.978
(-17.57 to 11.612)
-10.72
(-23.90 to 2.458)
3.Secondary Outcome
Title Analysis of Change From Baseline in Adaptive Test of Temporal Resolution (ATTR) on End-Point Visit Day 28
Hide Description Final Average GDT Within-Channel at Day 28: Change from Baseline; FAS Population
Time Frame 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS Population
Arm/Group Title AUT00063 (600 mg Capsules) (AUT00063 Placebo Capsules)
Hide Arm/Group Description:

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

AUT00063: 600 mg, orally, once a day, for 4 weeks

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

Placebo: orally, once a day, for 4 weeks

Overall Number of Participants Analyzed 36 39
Least Squares Mean (95% Confidence Interval)
Unit of Measure: ms
4.452
(1.306 to 7.598)
5.526
(2.661 to 8.392)
4.Secondary Outcome
Title To Further Investigate the Safety and Tolerability Profile of Repeat Administration of AUT00063 by Assessing Vital Signs, Physical Examination, Laboratory Exams and ECG
Hide Description Number of Subjects With At Least One Treatment Emergent Adverse Event
Time Frame 42 Days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AUT00063 (600 mg Capsules) Placebo (AUT00063 Placebo Capsules)
Hide Arm/Group Description:

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

AUT00063: 600 mg, orally, once a day, for 4 weeks

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

Placebo: orally, once a day, for 4 weeks

Overall Number of Participants Analyzed 38 40
Measure Type: Count of Participants
Unit of Measure: Participants
23
  60.5%
24
  60.0%
5.Secondary Outcome
Title Pharmacokinetic of AUT00063, Plasma Levels
Hide Description Exposure of AUT00063 ng/ml, in plasma levels at Day 28
Time Frame 28 Days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AUT00063 (600 mg Capsules) Placebo
Hide Arm/Group Description:

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

AUT00063: 600 mg, orally, once a day, for 4 weeks

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

Placebo: orally, once a day, for 4 weeks

Overall Number of Participants Analyzed 36 36
Mean (Standard Deviation)
Unit of Measure: ng
3470.61  (1290.679) 0  (0)
Time Frame The recording period for Adverse Events is the period starting from the Informed Consent signature until the safety close out visit or subject’s study participation ends; a total duration of up to 10 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AUT00063 (600 mg Capsules) Placebo (AUT00063 Placebo Capsules)
Hide Arm/Group Description

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

AUT00063: 600 mg, orally, once a day, for 4 weeks

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

Placebo: orally, once a day, for 4 weeks

All-Cause Mortality
AUT00063 (600 mg Capsules) Placebo (AUT00063 Placebo Capsules)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)      0/40 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
AUT00063 (600 mg Capsules) Placebo (AUT00063 Placebo Capsules)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/38 (0.00%)      1/40 (2.50%)    
Injury, poisoning and procedural complications     
Alcohol poisoning  1 [1]  0/38 (0.00%)  0 1/40 (2.50%)  1
1
Term from vocabulary, MedDRA Version 17.0
Indicates events were collected by systematic assessment
[1]
Acute Alcohol Intoxication
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AUT00063 (600 mg Capsules) Placebo (AUT00063 Placebo Capsules)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/38 (47.37%)      21/40 (52.50%)    
Ear and labyrinth disorders     
Tinnitus  1 [1]  4/38 (10.53%)  3/40 (7.50%) 
Gastrointestinal disorders     
Diarrhoea  1 [2]  3/38 (7.89%)  2/40 (5.00%) 
Nausea  1 [3]  2/38 (5.26%)  3/40 (7.50%) 
General disorders     
Fatigue  1 [4]  2/38 (5.26%)  0/40 (0.00%) 
Infections and infestations     
Gastroenteritis  1 [5]  0/38 (0.00%)  2/40 (5.00%) 
Upper respiratory tract infection  1 [6]  3/38 (7.89%)  2/40 (5.00%) 
Investigations     
Blood triglycerides increased  1 [7]  2/38 (5.26%)  0/40 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back Pain  1 [8]  1/38 (2.63%)  3/40 (7.50%) 
Nervous system disorders     
Dizziness  1 [9]  6/38 (15.79%)  1/40 (2.50%) 
Headache  1 [10]  4/38 (10.53%)  5/40 (12.50%) 
Somnolence  1 [11]  3/38 (7.89%)  0/40 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Sinus Congestion  1 [12]  1/38 (2.63%)  2/40 (5.00%) 
1
Term from vocabulary, MedDRA Version 17.0
Indicates events were collected by systematic assessment
[1]
Tinnitus
[2]
Diarrhoea
[3]
Nausea
[4]
Fatigue
[5]
Gastroenteritis
[6]
Upper respiratory tract infection
[7]
Triglycerides increased
[8]
Back Pain
[9]
Dizziness
[10]
Headache
[11]
Drowsiness
[12]
Sinus Congestion
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Clinical Project Manager
Organization: Autifony Therapeutics Ltd
Phone: +44 1438 906860
Responsible Party: Autifony Therapeutics Limited
ClinicalTrials.gov Identifier: NCT02345031     History of Changes
Other Study ID Numbers: AUT022063
First Submitted: January 19, 2015
First Posted: January 26, 2015
Results First Submitted: April 19, 2017
Results First Posted: September 19, 2017
Last Update Posted: August 9, 2018