FX-322 in Sensorineural Hearing Loss

Status Completed

Clinical Trial Summary

This is a phase 1/2 study of FX-322 at two dose levels compared to placebo in male and female adults otherwise healthy with stable sensorineural hearing loss.

Clinical Trial Description

Sensorineural hearing loss (SNHL) accounts for about 90% of all cases of hearing loss. The study will assess the safety of FX-322 (laduviglusib and sodium valproate) given as a single intratympanic injection in subjects with a medical history of sensorineural hearing loss that is associated with noise exposure or sudden hearing loss. Safety will be evaluated both systemically (lab and clinical monitoring) and locally (otoscopy and audiometry) in 24 subjects, and a blood PK profile of FX-322 will also be determined. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03616223
Study type	Interventional
Source	Frequency Therapeutics
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	July 3, 2018
Completion date	December 18, 2018

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00023036` - Clinical and Genetic Analysis of Enlarged Vestibular Aqueducts
Completed	`NCT03746613` - Clinal Evaluation of Navigation Based Functional Ear Surgery Using Image Guided and Robotically Assisted Techniques	N/A
Recruiting	`NCT05568329` - Appreciation for Music Processed by Hearing Aids	N/A
Withdrawn	`NCT05061758` - A Trial of LY3056480 in Patients With SNLH	Phase 2
Completed	`NCT01434446` - The Effect of Sound Stimulation on Hearing Ability	N/A
Completed	`NCT03212924` - Listening Effort in Cochlear Implant Users	N/A
Recruiting	`NCT06053190` - Effects of Clear Speech on Listening Effort and Memory in Sentence Processing	N/A
Completed	`NCT03718975` - Quality Control of CE-Certified Phonak Hearing Aids - 2018_28	N/A
Completed	`NCT06025097` - Intra-Tympanic Steroid With PRP Combination in Sensorineural Hearing Loss and Tinnitus.	Early Phase 1
Recruiting	`NCT04102215` - The Efficacy of a Minimally Invasive Direct Cochlear Access Via the HEARO Procedure	N/A
Recruiting	`NCT04108598` - The SeaSHeL National Prospective Cohort Study
Active, not recruiting	`NCT04750642` - Cochlear Implant With Dexamethasone Eluting Electrode Array	N/A
Completed	`NCT04120116` - FX-322 in Adults With Stable Sensorineural Hearing Loss	Phase 2
Recruiting	`NCT06223724` - Status Telemetry for Cochlear Implantations
Completed	`NCT02005822` - Congenital Cytomegalovirus: Efficacy of Antiviral Treatment	Phase 3
Suspended	`NCT02616172` - Autologous Bone Marrow Harvest and Transplant for Sensorineural Hearing Loss	Phase 1/Phase 2
Completed	`NCT02259595` - Study to Determine the Safety, Tolerability, and Pharmacokinetic Profile of HPN-07 and HPN-07 Plus NAC	Phase 1
Unknown status	`NCT01902914` - Effectiveness of P02 Digital Hearing Aids	Phase 1/Phase 2
Completed	`NCT00589511` - Nucleus Freedom Cochlear Implant System Pediatric Post-approval Study	N/A
Completed	`NCT03288753` - Comparison Between Neuro 1 and Neuro 2 Cochlear Implant Speech Processors	N/A