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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
15
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
Royal National Throat, Nose and Ear Hospital
London, United Kingdom
Manchester Royal Infirmary
Manchester, United Kingdom
Speech recognition tests
To compare % scores on a battery of speech tests after 28 days of AUT00063 compared to baseline and placebo
Time frame: 10 - 12 weeks
Direct stimulation tests
To compare rate discrimination and gap detection thresholds after 28 days of AUT00063 compared to baseline and placebo
Time frame: 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
Time frame: up to 15 weeks
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