QUIET-1: The Quest in Eliminating Tinnitus
Research type
Research Study
Full title
A Balanced Randomised Placebo Controlled Double-blind Phase IIa Study to Investigate the Efficacy and Safety of AUT00063 Versus Placebo in Subjective Tinnitus
IRAS ID
158372
Contact name
Jaydip Ray
Contact email
Sponsor organisation
Autifony Therapeutics Limited
Eudract number
2014-002179-27
Research summary
AUT00063 (the study medicine) is an experimental new medicine for treating hearing disorders, such as loss of hearing or tinnitus (a ‘ringing’ or buzzing noise in the ears). Hearing disorders are common in older people and have recently become more common in young people. There are no licensed drugs available for hearing loss or tinnitus. Reduced activity at certain sites in the brain (called “voltage-gated potassium channels”) has been linked to hearing loss. The study medicine has been developed to treat the brain component of hearing disorders.
The main purpose of this study is to demonstrate a clinically relevant improvement in tinnitus severity after repeat dosing of the study medicine or the placebo, in subjects with subjective tinnitus.
This will be determined by looking at a number of assessments (physical examinations, blood sampling, audiometric assessments, questionnaires, etc.) done on patients experiencing noise or age-related tinnitus. Each patient will be maximum 11 weeks in the study and will need to visit the clinic 5 times.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
14/YH/1090
Date of REC Opinion
29 Aug 2014
REC opinion
Further Information Favourable Opinion