Hearing LossPhase 2NCT02832128
Evaluating Possible Improvement in Speech and Hearing Tests After 28 Days of Dosing of the Study Drug AUT00063 Compared to Placebo (QuicKfire)
A Phase 2 study testing AUT00063 in people with Hearing Loss and Hearing Impairment, run by Autifony Therapeutics Limited at 4 sites in United Kingdom.
Trial summary
The objective of this pilot study is to explore whether repeat doses of AUT00063 can provide an indication of improvement in performance of tests across a battery of speech and hearing assessments in cochlear implant users. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Hearing Impairment
- 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
- 15 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- May 2016to Apr 2017
- 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
- Male or female aged ≥ 18 years.
- Native English speaking.
- Received a unilateral cochlear implant within the last 9 to 48 months for post-lingual deafness.
- Less than optimal speech perception at the time of enrolment (defined as a score of 25% to 95% for Bamford-Kowal-Bench (BKB) sentences.
- Fully trained and optimised at the time of enrolment.
- CI device working satisfactorily and no interventions in the 4 weeks prior to the first dose of study medication.
- Signed and dated informed consent.
Who cannot join
- Not able to understand and comply with the requirements of the study.
- CI undertaken primarily for the management of severe tinnitus.
- Moderate or severe depression or generalised anxiety.
- Currently taking or planning to take medications that are prohibited by the study protocol.
- History of important cardiac, endocrine, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major diseases deemed clinically significant.
- Clinically significant ECG abnormality or prolonged QT interval.
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- Screening laboratory safety test results outside the normal ranges that are deemed to be clinically significant by the investigator.
- Any acute disabling illness.
- Clinically significant alcohol or drug abuse.
- Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives of the investigational drug.
- For women: Pregnant or nursing.
- For men and women: Not willing or able to use adequate methods of contraception.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
University Hospitals Birmingham NHS Foundation Trust
Birmingham
Cambridge University Hospitals NHS Foundation Trust
Cambridge
Royal National Throat, Nose and Ear Hospital
London
Manchester Royal Infirmary
Manchester
About this study
Official title: A Pilot Double Blind Placebo Controlled Crossover Study to Explore Possible Benefits of AUT00063, An Oral Modulator of Voltage - Gated Potassium Channels , In Adults Post-lingual Unilateral Cochlear Implant Recipients
The objective of this pilot study is to explore whether repeat doses of AUT00063 can provide an indication of improvement in performance of tests across a battery of speech and hearing assessments in cochlear implant users.
Read the detailed description
Reduced activity at certain sites in the brain called "voltage-gated potassium channels", has been linked to hearing problems. The study drug, AUT00063, has been developed to help improve the recognition of speech by aiming to improve the action of the voltage-gated potassium channels in the hearing pathways in the brain and so help to treat the hearing problem.
The main purpose of this study is to find out whether AUT00063 can improve the understanding of speech after 28 days of treatment compared with a placebo (dummy drug which does not contain the study drug) in patients who have received a cochlear implant (CI) for post-lingual deafness.
Efficacy will be investigated through a number of assessments including speech recognition testing, parameters of central auditory processing measured using tests that involve direct stimulation via the CI, and questionnaires.
Safety assessments will also be conducted throughout the study including physical examinations, ECGs and blood sampling.
It is planned that up to 20 people who have received a cochlear implant within the last 9 to 36 months will take part in the study. The people will be recruited from around 4 hospital sites in the UK.
- Conditions
- Hearing Loss, Hearing Impairment
- Being tested
- AUT00063, Placebo
- Keywords
- Cochlear Implant
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AUT00063Drug
4 capsules of 200 mg AUT00063, to take orally with food for 4 weeks
PlaceboDrug
4 capsules of placebo, to take orally with food for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| AUT00063 - Placebo | Experimental | AUT00063 (800 mg/day) for 28 days, followed by a 2 to 4 week washout period before commencing the second 28-day dosing period with placebo Receives: Drug: AUT00063; Drug: Placebo |
| Placebo - AUT00063 | Experimental | Placebo for 28 days, followed by a 2 to 4 week washout period before commencing the second 28-day dosing period with AUT00063 (800 mg/day) Receives: Drug: AUT00063; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech recognition tests
To compare % scores on a battery of speech tests after 28 days of AUT00063 compared to baseline and placebo
Measured: 10 - 12 weeks
Secondary outcomes (2)
Direct stimulation tests
To compare rate discrimination and gap detection thresholds after 28 days of AUT00063 compared to baseline and placebo
Measured: 10 - 12 weeks
To further investigate the safety and tolerability profile of repeat administration of AUT00063
To investigate the safety and tolerability of AUT00063 by assessing vital signs, physical examination, laboratory exams and ECG
Measured: up to 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startMay 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Autifony Therapeutics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shakeel R Saeed, MD, FRCS (ORL), Principal investigator, Royal National Throat, Nose and Ear Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832128
- Sponsor's protocol ID
- AUT042063
- Other IDs
- 2015-003929-34, 2015
- Status last verified
- May 2017
- First submitted
- 4 Apr 2016
- Last updated
- 24 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Double Blind Placebo Controlled Crossover Study to Explore Possible Benefits of AUT00063, An Oral Modulator of Voltage - Gated Potassium Channels , In Adults Post-lingual Unilateral Cochlear Implant Recipients
- ClinicalTrials.gov ID
- NCT02832128
- Acronym / sponsor ID
- AUT042063
- Conditions
- Hearing Loss, Hearing Impairment
- Keywords
- Cochlear Implant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Autifony Therapeutics LimitedIndustry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 14 Jul 2016 (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.
The objective of this pilot study is to explore whether repeat doses of AUT00063 can provide an indication of improvement in performance of tests across a battery of speech and hearing assessments in cochlear implant users.
Detailed description
Reduced activity at certain sites in the brain called "voltage-gated potassium channels", has been linked to hearing problems. The study drug, AUT00063, has been developed to help improve the recognition of speech by aiming to improve the action of the voltage-gated potassium channels in the hearing pathways in the brain and so help to treat the hearing problem.
The main purpose of this study is to find out whether AUT00063 can improve the understanding of speech after 28 days of treatment compared with a placebo (dummy drug which does not contain the study drug) in patients who have received a cochlear implant (CI) for post-lingual deafness.
Efficacy will be investigated through a number of assessments including speech recognition testing, parameters of central auditory processing measured using tests that involve direct stimulation via the CI, and questionnaires.
Safety assessments will also be conducted throughout the study including physical examinations, ECGs and blood sampling.
It is planned that up to 20 people who have received a cochlear implant within the last 9 to 36 months will take part in the study. The people will be recruited from around 4 hospital sites in the UK.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AUT00063 - Placebo | Experimental | Drug: AUT00063, Drug: PlaceboAUT00063 (800 mg/day) for 28 days, followed by a 2 to 4 week washout period before commencing the second 28-day dosing period with placebo |
| Placebo - AUT00063 | Experimental | Drug: AUT00063, Drug: PlaceboPlacebo for 28 days, followed by a 2 to 4 week washout period before commencing the second 28-day dosing period with AUT00063 (800 mg/day) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female aged ≥ 18 years.
- Native English speaking.
- Received a unilateral cochlear implant within the last 9 to 48 months for post-lingual deafness.
- Less than optimal speech perception at the time of enrolment (defined as a score of 25% to 95% for Bamford-Kowal-Bench (BKB) sentences.
- Fully trained and optimised at the time of enrolment.
Key exclusion criteria (12 listed)
- Not able to understand and comply with the requirements of the study.
- CI undertaken primarily for the management of severe tinnitus.
- Moderate or severe depression or generalised anxiety.
- Currently taking or planning to take medications that are prohibited by the study protocol.
- History of important cardiac, endocrine, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major diseases deemed clinically significant.
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 |
|---|---|---|
| AUT000634 capsules of 200 mg AUT00063, to take orally with food for 4 weeks | Drug | AUT00063 - Placebo, Placebo - AUT00063 |
| Placebo4 capsules of placebo, to take orally with food for 4 weeks | Drug | AUT00063 - Placebo, Placebo - AUT00063 |
Primary outcome
Speech recognition tests
Time frame: 10 - 12 weeks
To compare % scores on a battery of speech tests after 28 days of AUT00063 compared to baseline and placebo
2 secondary outcomes
Direct stimulation tests
Time frame: 10 - 12 weeks
To further investigate the safety and tolerability profile of repeat administration of AUT00063
Time frame: up to 15 weeks
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 24 May 2017.
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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.
Shakeel R Saeed, MD, FRCS (ORL) principal investigator
Royal National Throat, Nose and Ear Hospital
4 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 Hearing Loss and Hearing Impairment, run by Autifony Therapeutics Limited at 4 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 7 inclusion and 12 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 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. 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?
Speech recognition tests (time frame: 10 - 12 weeks). 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 24 May 2017.