Victoria Sanchez, AuD, PhD; K. Paul Boyev, MD; Theresa Chisolm, PhD; Robert D. Frisina, PhD; Charles H Large, PhD
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 be 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.
