Safety of intratympanic injection of AM-101 in patients with acute inner ear tinnitus

Audiol Neurootol. 2011;16(6):388-97. doi: 10.1159/000322641. Epub 2011 Jan 21.

Abstract

Effective pharmacological treatments for tinnitus have proven elusive. Emerging evidence suggests that dysregulation of cochlear N-methyl-D-aspartate (NMDA) receptors may underlie aberrant excitation of the auditory nerve, which in turn is perceived as tinnitus. The blocking of these receptors thus represents a promising therapeutic approach. In a recent phase I/II clinical trial, the safety and local tolerance of intratympanic injections of the NMDA receptor antagonist AM-101 was evaluated for the first time in humans. The results from the double-blind, randomized, placebo-controlled study show that intratympanically injected AM-101 was well tolerated by study participants, and provided the first indications of therapeutic efficacy.

Publication types

  • Clinical Trial, Phase I
  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Cochlea / drug effects*
  • Double-Blind Method
  • Excitatory Amino Acid Antagonists / administration & dosage
  • Excitatory Amino Acid Antagonists / adverse effects*
  • Excitatory Amino Acid Antagonists / therapeutic use
  • Female
  • Humans
  • Male
  • Middle Aged
  • Receptors, N-Methyl-D-Aspartate / antagonists & inhibitors*
  • Tinnitus / drug therapy*
  • Treatment Outcome
  • Tympanic Membrane / drug effects*

Substances

  • Excitatory Amino Acid Antagonists
  • Receptors, N-Methyl-D-Aspartate