Intratympanic Administration of OTO-313 Reduces Tinnitus in Patients With Moderate to Severe, Persistent Tinnitus: A Phase 1/2 Study
Objective:
To evaluate the safety and exploratory efficacy of intratympanic administration of OTO-313 in patients with tinnitus.
Study Design:
Single intratympanic injection of OTO-313 evaluated in a randomized, double-blind, placebo-controlled Phase 1/2 clinical study.
Setting:
Tertiary referral centers.
Patients:
Patients with unilateral tinnitus (moderate–severe) with tinnitus duration 1 to 6 months.
Interventions:
Intratympanic OTO-313.
Main Outcome Measures:
Safety and change from baseline in tinnitus functional index (TFI), daily ratings of tinnitus loudness and annoyance, and patient global impression of change (PGIC).
Results:
OTO-313 was well-tolerated with lower incidence of adverse events than placebo. Mean TFI reduction from baseline favored OTO-313 at Week 2, 4, and 8. A clinically meaningful, 13-point improvement on the TFI was observed in 43% (6/14) of OTO-313 patients at both Weeks 4 and 8 versus 13% (2/16) of placebo patients (ad hoc responder analysis, p-value
Source: Otology and Neurotology - Category: ENT & OMF Tags: MEDICAL NEUROTOLOGY Source Type: research