Tinnitus, SubjectivePhase 2QUIET-1NCT02315508
Evaluating Possible Improvement in Tinnitus Severity After 28 Days Dosing of the Study Drug AUT00063 Compared to Placebo
A Phase 2 study testing AUT00063 in people with Tinnitus, Subjective, run by Autifony Therapeutics Limited at 18 sites in United Kingdom.
Trial summary
This study aims to demonstrate that the new medicine AUT00063 is effective and safe in the treatment of tinnitus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus, Subjective
- 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
- 91 participants
- Where
- 18 sitesUnited Kingdom
- Study dates
- Oct 2014to Dec 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking, who are UK residents registered with a UK General Practitioner;
- Experiencing stable tinnitus (consistent from day to day)
- Tinnitus has existed for not less than 6 months, and not more than 18 months - Contraceptive methods must be used before and for at least 30 days after the stop of the study treatment.
Who cannot join
- Severe hearing impairment such that verbal communication is unreliable;
- History of important cardiac, endocrine, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major diseases deemed clinically significant at the time of the study by the Investigator and which might be jeopardised by entering the study;
- Moderate or severe depression or generalised anxiety
- Participation in any clinical research study evaluating another investigational drug or therapy within 30 days of starting the investigational treatment
- Participation in hearing study, involving an intervention, within 3 months from last study visit;
- Central nervous system pathologies e.g. Multiple Sclerosis, Parkinson's disease;
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- Tinnitus as a concomitant symptom of a known otological condition (including but not limited to otitis externa, otitis media, otosclerosis, cholesteatoma, Ménière's disease or other vestibular problems, acoustic neuroma, or temporo-mandibular joint disorder);
- Pulsatile tinnitus (rhythmical sounds that often beat in time with the heartbeat);
- Intermittent tinnitus (comes and goes from one day to the next);
- Surgery or medical condition that might would be expected to significantly affect absorption of medicines;
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United Kingdom18 sites
Birmingham University Hospital
Birmingham, B15 2WB
Bradford Teaching Hospital
Bradford, BD9 6RJ
Bristol Royal Infirmary
Bristol, BS2 8HW
Cambridge University Hospitals NHS Trust
Cambridge, CB2 0QQ
Frimley Health NHS Foundation Trust
Frimley, GU16 7UJ
University College London Hospital NHS Foundation Trust
London, WC1E 6BT
The Pennine Acute Hospitals NHS Trust
Manchester, M8 5RB
Freeman Hospital
Newcastle, NE7 7DN
Norfolk and Norwich University Hospital Foundation Trust
Norwich, NR4 7UY
Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH
Derriford Plymouth NHS Trust
Plymouth, PL6 8DH
Portsmouth Hospitals NHS Trust
Portsmouth, PO6 3LY
Salford Royal Hospital
Salford, M6 8HD
Royal Hallamshire Hospital, Sheffield
Sheffield, S10 3BR, UK
Lister Hospital
Stevenage, SG1 4AB
University Hospital of North Staffordshire
Stoke-on-Trent, ST4 6QG
Shrewsbury and Telford Hospital NHS Trust
Telford, TF1 6TF
Wrightington Hospital
Wigan, WN6 9EP
About this study
Official title: A Balanced Randomised Placebo Controlled Double-blind Phase IIa Study to Investigate the Efficacy and Safety of AUT00063 Versus Placebo in Subjective Tinnitus
This study aims to demonstrate that the new medicine AUT00063 is effective and safe in the treatment of tinnitus.
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 has been developed to improve the action of these specific channels and so treat the brain component of these hearing problems.
The main purpose of this study is to try to demonstrate an improvement in the severity of tinnitus after 4 weeks of treatment with the study medicine or the placebo (dummy drug which does not contain the medication). 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.) and in case of any serious medical event during the study. The amount of drug in the blood will also be measured.
It is expected that up to 152 people with tinnitus may take part in the study. The study participants will be recruited at around 16 Hospital sites in the UK.
- Conditions
- Tinnitus, Subjective
- Being tested
- AUT00063, Placebo
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AUT00063Drug
Also called Experimental
800 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 | Experimental | 4 capsules of 200 mg of the new medicine, AUT00063, to take orally with food for 4 weeks. Receives: Drug: AUT00063 |
| Placebo | Placebo comparator | 4 capsules of placebo, to take orally 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 subjective Tinnitus after 4 weeks treatment
To compare the change from baseline (D1 to D28) of the Tinnitus Functional Index overall score between AUT00063 (800 mg) and placebo.
Measured: 28 days
Secondary outcomes (3)
To further investigate the safety and tolerability profile of repeat administration of AUT00063 (assessing vital signs, physical examination, laboratory exams and ECG)
To investigate the safety and tolerability of AUT00063 by assessing vital signs, physical examination, laboratory exams and ECG
Measured: 42 days
Change in Tinnitus Loudness matching after 4 weeks of treatment
Changes from baseline (D1) at Day 28 between treatment groups in Tinnitus loudness matching (LM).
Measured: 28 days
Pharmacokinetic of AUT00063 (Exposure of AUT00063 ng/ml, measured as AUT00063 plasma levels)
Exposure of AUT00063 ng/ml, measured as AUT00063 plasma levels at Day 28
Measured: at day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tinnitus, SubjectiveStudies 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
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Autifony Therapeutics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Nottingham
- Responsible party
- Sponsor
- Investigators
- Jaydip Ray, MD, Principal investigator, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02315508
- Sponsor's protocol ID
- AUT032063
- Acronym
- QUIET-1
- Status last verified
- Mar 2016
- First submitted
- 9 Dec 2014
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hall DA, Ray J, Watson J, Sharman A, Hutchison J, Harris P, Daniel M, Millar B, Large CH. A balanced randomised placebo controlled blinded phase IIa multi-centre study to investigate the efficacy and safety of AUT00063 versus placebo in subjective tinnitus: The QUIET-1 trial. Hear Res. 2019 Jun;377:153-166. doi: 10.1016/j.heares.2019.03.018. Epub 2019 Mar 27.
PubMed 30939361
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Balanced Randomised Placebo Controlled Double-blind Phase IIa Study to Investigate the Efficacy and Safety of AUT00063 Versus Placebo in Subjective Tinnitus
- ClinicalTrials.gov ID
- NCT02315508
- Acronym / sponsor ID
- QUIET-1 / AUT032063
- Conditions
- Tinnitus, Subjective
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Autifony Therapeutics LimitedIndustry (pharma, biotech, devices)
- Collaborators
- University of Nottingham
- Study start
- Oct 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 12 Dec 2014 (estimated)
- Results
- Not posted in the source record
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 new medicine AUT00063 is effective and safe in the treatment of tinnitus.
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 has been developed to improve the action of these specific channels and so treat the brain component of these hearing problems.
The main purpose of this study is to try to demonstrate an improvement in the severity of tinnitus after 4 weeks of treatment with the study medicine or the placebo (dummy drug which does not contain the medication). 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.) and in case of any serious medical event during the study. The amount of drug in the blood will also be measured.
It is expected that up to 152 people with tinnitus may take part in the study. The study participants will be recruited at around 16 Hospital sites in the UK.
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 | Experimental | Drug: AUT000634 capsules of 200 mg of the new medicine, AUT00063, to take orally with food for 4 weeks. |
| Placebo | Placebo comparator | Drug: Placebo4 capsules of placebo, to take orally with food for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English-speaking, who are UK residents registered with a UK General Practitioner;
- Experiencing stable tinnitus (consistent from day to day)
- Tinnitus has existed for not less than 6 months, and not more than 18 months - Contraceptive methods must be used before and for at least 30 days after the stop of the study treatment.
Key exclusion criteria (10 listed)
- Severe hearing impairment such that verbal communication is unreliable;
- History of important cardiac, endocrine, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major diseases deemed clinically significant at the time of the study by the Investigator and which might be jeopardised by entering the study;
- Moderate or severe depression or generalised anxiety
- Participation in any clinical research study evaluating another investigational drug or therapy within 30 days of starting the investigational treatment
- Participation in hearing study, involving an intervention, within 3 months from last study visit;
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: Experimental800 mg orally, once a day, for 4 weeks | Drug | AUT00063 |
| PlaceboAlso: Comparatororally, once a day, for 4 weeks | Drug | Placebo |
Primary outcome
Change in subjective Tinnitus after 4 weeks treatment
Time frame: 28 days
To compare the change from baseline (D1 to D28) of the Tinnitus Functional Index overall score between AUT00063 (800 mg) and placebo.
3 secondary outcomes
To further investigate the safety and tolerability profile of repeat administration of AUT00063 (assessing vital signs, physical examination, laboratory exams and ECG)
Time frame: 42 days
Change in Tinnitus Loudness matching after 4 weeks of treatment
Time frame: 28 days
Pharmacokinetic of AUT00063 (Exposure of AUT00063 ng/ml, measured as AUT00063 plasma levels)
Time frame: at day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
- Derived from this study: PubMed 30939361Hall DA, Ray J, Watson J, Sharman A, Hutchison J, Harris P, Daniel M, Millar B, Large CH. A balanced randomised placebo controlled blinded phase IIa multi-centre study to investigate the efficacy and safety of AUT00063 versus placebo in subjective tinnitus: The QUIET-1 trial. Hear Res. 2019 Jun;377:153-166. doi: 10.1016/j.heares.2019.03.018. Epub 2019 Mar 27.
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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.
Jaydip Ray, MD principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust
18 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 Tinnitus, Subjective, run by Autifony Therapeutics Limited at 18 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. 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 31 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 subjective Tinnitus after 4 weeks 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?
On the ClinicalTrials.gov record for NCT02315508, which also lists 1 linked publication.
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 31 Mar 2016.