Hearing Loss Clinical Trial
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.
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.
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