NCT02345031

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

September 19, 2017

Completed
Last Updated

August 9, 2018

Status Verified

August 1, 2018

Enrollment Period

1.3 years

First QC Date

January 19, 2015

Results QC Date

April 19, 2017

Last Update Submit

August 8, 2018

Conditions

Age-Related Hearing Loss

Keywords

hearing lossspeech-in-noise

Outcome Measures

Primary Outcomes (1)

  • 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).

    28 days

Secondary Outcomes (4)

  • Analysis of Change From Baseline in Adaptive Test of Temporal Resolution (ATTR) on End-Point Visit Day 28

    28 days

  • Analysis of Change From Baseline in Adaptive Test of Temporal Resolution (ATTR) on End-Point Visit Day 28

    28 days

  • To Further Investigate the Safety and Tolerability Profile of Repeat Administration of AUT00063 by Assessing Vital Signs, Physical Examination, Laboratory Exams and ECG

    42 Days

  • Pharmacokinetic of AUT00063, Plasma Levels

    28 Days

Study Arms (2)

AUT00063 (600 mg capsules)

ACTIVE COMPARATOR

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

Drug: AUT00063

(AUT00063 placebo capsules)

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

AUT00063DRUG

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

Also known as: Experimental
AUT00063 (600 mg capsules)
PlaceboDRUG

orally, once a day, for 4 weeks

Also known as: Comparator
(AUT00063 placebo capsules)

Eligibility Criteria

Age50 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (13)

Sacramento ENT

Sacramento, California, 95815, United States

Location

Colorado ENT and Allergy

Colorado Springs, Colorado, 80909, United States

Location

ENT Associates of South Florida

Boca Raton, Florida, 33487, United States

Location

QPS MRA (Miami Research Associates)

Miami, Florida, 33143, United States

Location

University of South Florida

Tampa, Florida, 33620, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55095, United States

Location

The University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Long Island Jewish Medical Center

New Hyde Park, New York, 11042, United States

Location

PMG Research Inc.

Wilmington, North Carolina, 28401, United States

Location

Piedmont Ear, Nose, & Throat Associates

Winston-Salem, North Carolina, 27103, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Jean Brown Research

Murray, Utah, 84107, United States

Location

MeSH Terms

Conditions

PresbycusisHearing Loss

Interventions

AUT00063

Condition Hierarchy (Ancestors)

Hearing Loss, SensorineuralHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Clinical Project Manager
Organization
Autifony Therapeutics Ltd
info@autifony.com
+44 1438 906860

Study Officials

  • Robert Frisina, PhD

    Director Global Center for Hearing and Speech Research

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2015

First Posted

January 26, 2015

Study Start

January 1, 2015

Primary Completion

May 1, 2016

Study Completion

June 1, 2016

Last Updated

August 9, 2018

Results First Posted

September 19, 2017

Record last verified: 2018-08

Locations

US(13)