Intratympanic Administration of OTO-313 Reduces Tinnitus in Patients With Moderate to Severe, Persistent Tinnitus: A Phase 1/2 Study
| Autor: | Kenneth S. Maxwell, Gordon McMurry, Jeffery J Anderson, Huiying J. Hou, David M. Baguley, Grant D. Searchfield, Ines Hoffmann, Fabrice Piu, James M Robinson |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Moderate to severe
Referral OTO-313 Placebo Clinical study Tinnitus Double-Blind Method Medical Neurotology otorhinolaryngologic diseases Humans Medicine In patient Adverse effect gacyclidine Injection Intratympanic business.industry Outcome measures Sensory Systems Treatment Outcome Otorhinolaryngology Anesthesia sense organs Neurology (clinical) medicine.symptom business |
| Zdroj: | Otology & Neurotology |
| ISSN: | 1531-7129 1537-4505 |
| Popis: | 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 |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|