Tinnitus, Subjective Clinical Trial
Official title:
A Balanced Randomised Placebo Controlled Double-blind Phase IIa Study to Investigate the Efficacy and Safety of AUT00063 Versus Placebo in Subjective Tinnitus
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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