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CC BY-NC-ND 4.0 · J Am Acad Audiol 2021; 32(10): 670-694
DOI: 10.1055/s-0041-1735522
DOI: 10.1055/s-0041-1735522
Review Article
Special Issue on Hearing Therapeutics and Protective Therapies
Investigational Medicinal Products for the Inner Ear: Review of Clinical Trial Characteristics in ClinicalTrials.gov
Funding/Disclosure CL is currently supported by USAMRAA W81XWH-19-C-0054, JPC-8/SRMRP W81XWH1820014, NIH-NIDCD 1R01DC014088, 3M Inc., and the Emilie and Phil Schepps Professorship in Hearing Science. CL has previously received contract funding and/or clinical trial material from industry partners including Sound Pharmaceuticals, Inc., Edison Pharmaceuticals, Inc., and Hearing Health Science, Inc. The views expressed in this article are those of the author and do not reflect the official policy or position of the Department of the Army, Department of the Defense, or the U.S. Government.
Abstract
Background The previous 30 years have provided information on the mechanisms of cell death in the inner ear after noise exposure, ototoxic drug injury, and during aging, and clinical trials have emerged for all of these acquired forms of hearing loss. Sudden hearing loss is less well understood, but restoration of hearing after sudden hearing loss is also a long-standing drug target, typically using steroids as an intervention but with other agents of interest as well.
Purpose The purpose of this review was to describe the state of the science regarding clinical testing of investigational medicinal products for the inner ear with respect to treatment or prevention of acquired hearing loss.
Data Collection and Analysis Comprehensive search and summary of clinical trials listed in the National Library of Medicine (www.ClinicalTrials.gov) database identified 61 clinical trials.
Results Study phase, status, intervention, and primary, secondary, and other outcomes are summarized for studies assessing prevention of noise-induced hearing loss, prevention of drug-induced hearing loss, treatment of stable sensorineural hearing loss, and treatment of sudden sensorineural hearing loss.
Conclusion This review provides a comprehensive summary of the state of the science with respect to investigational medicinal products for the inner ear evaluated in human clinical trials, and the current challenges for the field.
Keywords
otoacoustic emissions - clinical trial - ototoxicity - noise induced hearing loss - investigational medicinal product - sensorineural hearing lossDisclaimer
Any mention of a product, service, or procedure in the Journal of the American Academy of Audiology does not constitute an endorsement of the product, service, or procedure by the American Academy of Audiology.
Publication History
Received: 22 February 2021
Accepted: 21 July 2020
Article published online:
24 May 2022
© 2022. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)
Thieme Medical Publishers, Inc.
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