Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 04 Jan 2018
At a glance
- Drugs Brimapitide (Primary)
- Indications Sensorineural hearing loss
- Focus Registrational; Therapeutic Use
- Acronyms ASSENT
- Sponsors Auris Medical
- 04 Jan 2018 According to an Auris Medical media release, the company plans to discuss the accumulated safety and efficacy data from the trial and the regulatory pathway with the FDA and EMA in the second quarter of 2018.
- 04 Jan 2018 According to an Auris Medical media release, the company expects data from a further 31 patients towards the end of the first quarter of 2018. The data will also be submitted for peer review publication and presentation at a medical meeting in 2018.
- 08 Dec 2017 Planned End Date changed from 1 Jun 2018 to 1 Mar 2018.