Age-Related Hearing LossPhase 2CLARITY-1NCT02345031
Efficacy and Safety of AUT00063 Versus Placebo in Age-Related Hearing Loss
A Phase 2 study testing AUT00063 in people with Age-Related Hearing Loss, run by Autifony Therapeutics Limited at 13 sites in United States.
Trial summary
This study aims to demonstrate that the investigational drug AUT00063 is effective and safe in the treatment of age-related hearing loss. Read more about this study
- Who is it for?
- Ages 50 to 89 years
- Conditions the study is for
- Age-Related Hearing Loss
- What is being tested?
- AUT00063
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 13 sitesUnited States
- Study dates
- Jan 2015to Jun 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
ENT Associates of South Florida
Boca Raton, Florida, 33487
Colorado ENT and Allergy
Colorado Springs, Colorado, 80909
The University of Mississippi Medical Center
Jackson, Mississippi, 39216
University of Louisville
Louisville, Kentucky, 40202
QPS MRA (Miami Research Associates)
Miami, Florida, 33143
Jean Brown Research
Murray, Utah, 84107
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Long Island Jewish Medical Center
New Hyde Park, New York, 11042
Mayo Clinic
Rochester, Minnesota, 55095
Sacramento ENT
Sacramento, California, 95815
University of South Florida
Tampa, Florida, 33620
PMG Research Inc.
Wilmington, North Carolina, 28401
Piedmont Ear, Nose, & Throat Associates
Winston-Salem, North Carolina, 27103
About this study
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]
This study aims to demonstrate that the investigational drug AUT00063 is effective and safe in the treatment of age-related hearing loss.
Read the 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.
- Conditions
- Age-Related Hearing Loss
- Being tested
- AUT00063, Placebo
- Keywords
- hearing loss, speech-in-noise
- Medical subject headings
- Presbycusis, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AUT00063Drug
Also called Experimental
600 mg, orally, once a day, for 4 weeks
PlaceboDrug
Also called Comparator
orally, once a day, for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: AUT00063 |
| (AUT00063 placebo capsules) | Placebo comparator | 3 capsules of placebo, to take orally once daily with food for 4 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 28 days
Secondary outcomes (4)
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
Measured: 28 days
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
Measured: 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
Number of Subjects With At Least One Treatment Emergent Adverse Event
Measured: 42 Days
Pharmacokinetic of AUT00063, Plasma Levels
Exposure of AUT00063 ng/ml, in plasma levels at Day 28
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionMay 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Age-Related Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Autifony Therapeutics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Frisina, PhD, Principal investigator, Director Global Center for Hearing and Speech Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345031
- Sponsor's protocol ID
- AUT022063
- Acronym
- CLARITY-1
- Status last verified
- Aug 2018
- First submitted
- 19 Jan 2015
- Last updated
- 9 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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]
- ClinicalTrials.gov ID
- NCT02345031
- Acronym / sponsor ID
- CLARITY-1 / AUT022063
- Conditions
- Age-Related Hearing Loss
- Keywords
- hearing loss, speech-in-noise
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Autifony Therapeutics LimitedIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 26 Jan 2015 (estimated)
- Results
- Posted 19 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AUT00063 (600 mg capsules) | Active comparator | Drug: AUT000633 capsules of 200 mg of the investigational drug AUT00063, to take orally once daily with food for 4 weeks |
| (AUT00063 placebo capsules) | Placebo comparator | Drug: Placebo3 capsules of placebo, to take orally once daily with food for 4 weeks |
Who may qualify
- Ages
- 50 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AUT00063Also: Experimental600 mg, orally, once a day, for 4 weeks | Drug | AUT00063 (600 mg capsules) |
| PlaceboAlso: Comparatororally, once a day, for 4 weeks | Drug | (AUT00063 placebo capsules) |
Primary outcome
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).
4 secondary outcomes
Analysis of Change From Baseline in Adaptive Test of Temporal Resolution (ATTR) on End-Point Visit Day 28
Time frame: 28 days
Analysis of Change From Baseline in Adaptive Test of Temporal Resolution (ATTR) on End-Point Visit Day 28
Time frame: 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
Time frame: 42 Days
Pharmacokinetic of AUT00063, Plasma Levels
Time frame: 28 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Frisina, PhD principal investigator
Director Global Center for Hearing and Speech Research
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AUT00063 in people with Age-Related Hearing Loss, run by Autifony Therapeutics Limited at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hearing Loss After 4 Weeks of Treatment (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2018.