Evaluating Possible Improvement in Tinnitus Severity After 28 Days Dosing of the Study Drug AUT00063 Compared to Placebo
NCT ID: NCT02315508
Last Updated: 2016-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
91 participants
INTERVENTIONAL
2014-10-31
2015-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AUT00063
4 capsules of 200 mg of the new medicine, AUT00063, to take orally with food for 4 weeks.
AUT00063
800 mg orally, once a day, for 4 weeks
Placebo
4 capsules of placebo, to take orally with food for 4 weeks.
Placebo
orally, once a day, for 4 weeks
Interventions
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AUT00063
800 mg orally, once a day, for 4 weeks
Placebo
orally, once a day, for 4 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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;
* 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;
18 Years
ALL
No
Sponsors
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University of Nottingham
OTHER
Autifony Therapeutics Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Jaydip Ray, MD
Role: PRINCIPAL_INVESTIGATOR
Sheffield Teaching Hospitals NHS Foundation Trust
Locations
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Birmingham University Hospital
Birmingham, , United Kingdom
Bradford Teaching Hospital
Bradford, , United Kingdom
Bristol Royal Infirmary
Bristol, , United Kingdom
Cambridge University Hospitals NHS Trust
Cambridge, , United Kingdom
Frimley Health NHS Foundation Trust
Frimley, , United Kingdom
University College London Hospital NHS Foundation Trust
London, , United Kingdom
The Pennine Acute Hospitals NHS Trust
Manchester, , United Kingdom
Freeman Hospital
Newcastle, , United Kingdom
Norfolk and Norwich University Hospital Foundation Trust
Norwich, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Derriford Plymouth NHS Trust
Plymouth, , United Kingdom
Portsmouth Hospitals NHS Trust
Portsmouth, , United Kingdom
Salford Royal Hospital
Salford, , United Kingdom
Royal Hallamshire Hospital, Sheffield
Sheffield, , United Kingdom
Lister Hospital
Stevenage, , United Kingdom
University Hospital of North Staffordshire
Stoke-on-Trent, , United Kingdom
Shrewsbury and Telford Hospital NHS Trust
Telford, , United Kingdom
Wrightington Hospital
Wigan, , United Kingdom
Countries
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References
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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.
Other Identifiers
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AUT032063
Identifier Type: -
Identifier Source: org_study_id