Evaluating Possible Improvement in Tinnitus Severity After 28 Days Dosing of the Study Drug AUT00063 Compared to Placebo

NCT02315508 ↗

Phase 2 Completed 91 enrolled Autifony Therapeutics Limited University of Nottingham · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study aims to demonstrate that the new medicine AUT00063 is effective and safe in the treatment of tinnitus.

Timeline

Start: 2014-10
Primary completion: 2015-12
Completion: 2015-12

Outcome

Missed primary endpoint

paper with respect to clinical benefit findings indicated that AUT00063 was not effective in alleviating tinnitus symptoms (1.56 point change in Tinnitus Functional Index). PMID 30939361 ↗

release “Headline data from QUIET-1 confirm lack of efficacy of AUT00063 in the treatment of people with mild-to-moderate tinnitus” autifony.com ↗

Publications

Hall DA, Ray J, Watson J, Sharman A, Hutchison J, Harris P, Daniel M, Millar B, Large CH. A balanced randomised placebo controlled blinded phase IIa multi-centre study to investigate the efficacy and safety of AUT00063 versus placebo in subjective tinnitus: The QUIET-1 trial. Hear Res. 2019 Jun;377:153-166. doi: 10.1016/j.heares.2019.03.018. Epub 2019 Mar 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AUT00063	Unknown	800 mg	Oral