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CLARITY-1 Trial Results and Implications for Future Audiology-Related Pharmaceutical Trials
EP27007
Poster Title: CLARITY-1 Trial Results and Implications for Future Audiology-Related Pharmaceutical Trials
Submitted on 07 Feb 2018
Author(s): Victoria Sanchez, K. Paul Boyev, Theresa Chisolm, Robert D. Frisinsa, John Hutchison, Charles Large
Affiliations: 1Auditory Rehabilitation & Clinical Trials Laboratory, 2Global Center for Hearing & Speech Research, 3Dept. of Communication Sciences and Disorders, 4Dept. of Otolaryngology – Head and Neck Surgery; 5Dept. Chemical & Biomedical Engineering, University of South Florida, Tampa, FL, USA; 6Autifony Therapeutics Ltd., London, UK
This poster was presented at USF Health Research Day
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Poster Information
Abstract: Advancements in potential pharmaceutical therapies for audiology-related disorders require audiologists to increase their ability to design and participate in clinical trials. Logistical lessons learned from a recent Phase IIa clinical trial (CLARITY-1; ID#NCT02345031) assessing the efficacy and safety of AUT00063, a novel small molecule that positively modulates voltage-gated potassium channels (Kv3), will be presented. Kv3 channels, which are
important for auditory neuron function, decline with age in the auditory brainstem. AUT00063 may improve neural synchrony and temporal processing,and, thus is a promising therapy for age-related hearing loss (ARHL). CLARITY-1, a multi-site, randomized double-blind, placebo-controlled, parallel group study, examined AUT00063’s efficacy and safety in 78 adults (50-89 years) with ARHL. From baseline to 28 days, both active and placebo groups
improved on the primary outcome measure, Quick Speech-in-Noise test, but the between-group difference was not statistically significant (p=0.06).
Additionally, there were no significant between-group differences on secondary behavioral or self-report measures. AUT00063, however, was found to b
safe and well tolerated. The safety profile was commendable and the trial data were of high quality, with excellent compliance and retention, thus, allowing for a conclusive outcome. Implications for future pharmaceutical studies including design, recruitment, and outcome measures will be discussed.
Summary: Advancements in potential pharmaceutical therapies for audiology-related disorders require audiologists to increase their ability to design and participate in clinical trials. Logistical lessons learned from a recent Phase IIa clinical trial (CLARITY-1; ID#NCT02345031) assessing the efficacy and safety of AUT00063, a novel small molecule that positively modulates voltage-gated potassium channels (Kv3), will be presented. Report abuse »
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