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Phase 2 Clinical Trials: D-Methionine to Reduce Noise-Induced Hearing Loss
Technical Report,01 Mar 2011,30 Apr 2016
Southern Illinois University School of Medicine Springfield United States
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The purpose of this clinical trial was to determine if an oral D-methionine liquid suspension could prevent noise-induced hearing loss NIHL and tinnitus in our troops. This prospective study was a randomized, double-blind, placebo-controlled Phase 3 clinical trial. The goal was to develop a safe oral pharmacologic agent for noise exposures exceeding hearing protective device protective capabilities. The study population included Drill Sergeant DS instructor trainees at Fort Jackson, SC. At the end of this grant period, we enrolled 457 subjects, randomized 305 subjects, and 235 have completed all phases of the trial. Study drug was well tolerated with no reported serious adverse events. The IND, prepared and approved by FDA during this grant period, was transferred to a new biotech company, MetArmor, Inc. effective May 30, 2016. Enrollment continued with supplemental funding from MetArmor with an interim analysis in July 2016. The preliminary results of the interim analysis are included.
APPROVED FOR PUBLIC RELEASE