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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 : September 19, 2017
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
AUT00063 (600 mg Capsules)

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

(AUT00063 Placebo Capsules)

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

Placebo: orally, once a day, for 4 weeks


Participant Flow:   Overall Study
    AUT00063 (600 mg Capsules)   (AUT00063 Placebo Capsules)
STARTED   38   40 
COMPLETED   37   39 
NOT COMPLETED   1   1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
AUT00063 (600 mg Capsules)

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

(AUT00063 Placebo Capsules)

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

Placebo: orally, once a day, for 4 weeks

Total Total of all reporting groups

Baseline Measures
   AUT00063 (600 mg Capsules)   (AUT00063 Placebo Capsules)   Total 
Overall Participants Analyzed 
[Units: Participants]
 38   40   78 
Age [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed   37   39   76 
<=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] Demographic data are listed from Full Analysis Set, excludes 2 subjects.
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed   37   39   76 
Female      15  40.5%      17  43.6%      32  42.1% 
Male      22  59.5%      22  56.4%      44  57.9% 
[1] Demographics data are listed from Full Analysis Set, excludes 2 subjects
Race/Ethnicity, Customized [1] 
[Units: Participants]
Count of Participants
     
Race       
Participants Analyzed   37   39   76 
White/Caucasian      36  97.3%      38  97.4%      74  97.4% 
Black/African-American      1   2.7%      1   2.6%      2   2.6% 
[1] Demographic data are listed from Full Analysis Set, excludes 2 subjects
Race/Ethnicity, Customized [1] 
[Units: Participants]
Count of Participants
     
Ethnicity       
Participants Analyzed   37   39   76 
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] Demographic data are listed from Full Analysis Set, excludes 2 subjects
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States       
Participants Analyzed   38   40   78 
United States   38   40   78 
QuickSIN SNR-50 Score (dB) [1] [2] 
[Units: Decibels (dB)]
Mean (Standard Deviation)
     
Participants Analyzed   37   39   76 
   7.00  (1.963)   7.11  (1.991)   7.06  (1.965) 
[1] 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] QuickSIN data are listed from Full Analysis set, excludes 2 subjects


  Outcome Measures

1.  Primary:   Change in Hearing Loss After 4 Weeks of Treatment   [ Time Frame: 28 days ]

2.  Secondary:   Analysis of Change From Baseline in Adaptive Test of Temporal Resolution (ATTR) on End-Point Visit Day 28   [ Time Frame: 28 days ]

3.  Secondary:   Analysis of Change From Baseline in Adaptive Test of Temporal Resolution (ATTR) on End-Point Visit Day 28   [ Time Frame: 28 days ]

4.  Secondary:   Pharmacokinetic of AUT00063, Plasma Levels   [ Time Frame: 28 Days ]

5.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: info@autifony.com



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: September 19, 2017