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Intratympanic Administration of OTO-313 Reduces Tinnitus in Patients With Moderate to Severe, Persistent Tinnitus: A Phase 1/2 Study
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. PATI...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Lippincott Williams & Wilkins
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8584222/ https://www.ncbi.nlm.nih.gov/pubmed/34629442 http://dx.doi.org/10.1097/MAO.0000000000003369 |
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author | Maxwell, Kenneth S. Robinson, James M. Hoffmann, Ines Hou, Huiying J. Searchfield, Grant Baguley, David M. McMurry, Gordon Piu, Fabrice Anderson, Jeffery J. |
author_facet | Maxwell, Kenneth S. Robinson, James M. Hoffmann, Ines Hou, Huiying J. Searchfield, Grant Baguley, David M. McMurry, Gordon Piu, Fabrice Anderson, Jeffery J. |
author_sort | Maxwell, Kenneth S. |
collection | PubMed |
description | 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 < 0.05). Reductions in daily ratings of tinnitus loudness and annoyance favored OTO-313 compared with placebo. In OTO-313 responders, a strong correlation existed between change from baseline in TFI score and changes in tinnitus loudness, tinnitus annoyance, and PGIC. CONCLUSIONS: OTO-313 was well-tolerated and demonstrated a higher proportion of responders than placebo across consecutive visits (Weeks 4 and 8) supporting further clinical development of OTO-313 for the treatment of tinnitus. |
format | Online Article Text |
id | pubmed-8584222 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Lippincott Williams & Wilkins |
record_format | MEDLINE/PubMed |
spelling | pubmed-85842222021-11-12 Intratympanic Administration of OTO-313 Reduces Tinnitus in Patients With Moderate to Severe, Persistent Tinnitus: A Phase 1/2 Study Maxwell, Kenneth S. Robinson, James M. Hoffmann, Ines Hou, Huiying J. Searchfield, Grant Baguley, David M. McMurry, Gordon Piu, Fabrice Anderson, Jeffery J. Otol Neurotol Medical Neurotology 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 < 0.05). Reductions in daily ratings of tinnitus loudness and annoyance favored OTO-313 compared with placebo. In OTO-313 responders, a strong correlation existed between change from baseline in TFI score and changes in tinnitus loudness, tinnitus annoyance, and PGIC. CONCLUSIONS: OTO-313 was well-tolerated and demonstrated a higher proportion of responders than placebo across consecutive visits (Weeks 4 and 8) supporting further clinical development of OTO-313 for the treatment of tinnitus. Lippincott Williams & Wilkins 2021-12 2021-10-08 /pmc/articles/PMC8584222/ /pubmed/34629442 http://dx.doi.org/10.1097/MAO.0000000000003369 Text en Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of Otology & Neurotology, Inc. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0 (https://creativecommons.org/licenses/by-nc-nd/4.0/) |
spellingShingle | Medical Neurotology Maxwell, Kenneth S. Robinson, James M. Hoffmann, Ines Hou, Huiying J. Searchfield, Grant Baguley, David M. McMurry, Gordon Piu, Fabrice Anderson, Jeffery J. Intratympanic Administration of OTO-313 Reduces Tinnitus in Patients With Moderate to Severe, Persistent Tinnitus: A Phase 1/2 Study |
title | Intratympanic Administration of OTO-313 Reduces Tinnitus in Patients With Moderate to Severe, Persistent Tinnitus: A Phase 1/2 Study |
title_full | Intratympanic Administration of OTO-313 Reduces Tinnitus in Patients With Moderate to Severe, Persistent Tinnitus: A Phase 1/2 Study |
title_fullStr | Intratympanic Administration of OTO-313 Reduces Tinnitus in Patients With Moderate to Severe, Persistent Tinnitus: A Phase 1/2 Study |
title_full_unstemmed | Intratympanic Administration of OTO-313 Reduces Tinnitus in Patients With Moderate to Severe, Persistent Tinnitus: A Phase 1/2 Study |
title_short | Intratympanic Administration of OTO-313 Reduces Tinnitus in Patients With Moderate to Severe, Persistent Tinnitus: A Phase 1/2 Study |
title_sort | intratympanic administration of oto-313 reduces tinnitus in patients with moderate to severe, persistent tinnitus: a phase 1/2 study |
topic | Medical Neurotology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8584222/ https://www.ncbi.nlm.nih.gov/pubmed/34629442 http://dx.doi.org/10.1097/MAO.0000000000003369 |
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