AUDIBLE-S
Research type
Research Study
Full title
A two- part, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of SENS-401 in subjects with severe or profound sudden sensorineural hearing loss
IRAS ID
248645
Contact name
Anne Schilder
Contact email
Sponsor organisation
SENSORION SA
Eudract number
2018-000812-47
Duration of Study in the UK
1 years, 8 months, 20 days
Research summary
Summary of Research
Sudden sensorineural hearing loss (SSNHL) is a rapid-onset, occurring over a 72-hour period, of a personal sensation of hearing loss in one or both ears. This is characterised by the sudden decrease in hearing of at least 30 decibels (dB) affecting at least 3 frequencies.
Sensorineural hearing loss is caused by death of the ear hair cells in the cochlea (portion of the inner ear that looks like a snail shell) and neural loss involving the hearing nerve. The majority of cases reported are an unknown (idiopathic) cause.
SSNHL a rare, serious and debilitating condition. Hearing loss adversely affects communication, speech perception in noisy environments, and social interaction. Patients suffering from SSNHL can also experience tinnitus (ringing in the ear) and/or vertigo (spinning sensation in the ear) that can negatively impact their quality of life (QoL).
There is no standardized treatment for SSNHL. However, corticosteroids are usually given to patients with SSNHL as a standard of care.
SENS-401 is thought to reduce hearing loss by restoring the function of auditory (ear) cells, which transmit the information to the brain. SENS-401 was able to improve hearing loss in specific animal models.
The study is a 2- part, multicenter, double-blind, randomized, placebo-controlled study of SENS-401 administered orally twice daily (BID for 28 days, with an 8-week follow-up. In the first part, 2 doses of SENS-401 29 mg/day and 43.5 mg/day (respectively 20 mg and 30 mg free base) will be tested. In the second part, only the dose that demonstrated efficacy in Part 1 will be tested.
SENS-401 or placebo will be given on top of the “standard of care” oral corticosteroids under the responsibility of the Investigator.
This is a multicentre study which will take place across North America, European countries, Turkey and Israel. It is anticipated that approximately 458 patients will be recruited worldwide.
Summary of Results
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REC name
London - Central Research Ethics Committee
REC reference
18/LO/1471
Date of REC Opinion
7 Nov 2018
REC opinion
Further Information Favourable Opinion