This study aims to demonstrate that the new medicine AUT00063 is effective and safe in the treatment of tinnitus.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
91
Birmingham University Hospital
Birmingham, United Kingdom
Bradford Teaching Hospital
Bradford, United Kingdom
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.
Time frame: 28 days
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
Time frame: 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).
Time frame: 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
Time frame: at day 28
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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
...and 8 more locations