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FX-322 in Adults With Stable Sensorineural Hearing Loss | Clinical Trials | Clareo Health

COMPLETEDPHASE2

FX-322 in Adults With Stable Sensorineural Hearing Loss

A Phase 2a, Prospective, Randomized, Double-Blind, Placebo-Controlled, Single and Repeat-Dose, Multicenter, Exploratory Efficacy Study of FX-322 Administered by Intratympanic Injection in Adults With Stable Sensorineural Hearing Loss

NCT04120116•Frequency Therapeutics

View on ClinicalTrials.gov

Summary

This is a phase 2a single and repeat dose exploratory efficacy study of intratympanic FX-322 compared to placebo in healthy male and female adults with stable sensorineural hearing loss.

Detailed Description

Sensorineural hearing loss (SNHL) accounts for about 90% of all cases of hearing loss. This phase 2a study will assess the exploratory efficacy, as well as the local and systemic safety of single and repeat intratympanic doses of FX-322 compared to placebo in approximately 96 subjects with stable mild to moderately severe sensorineural hearing loss, with a medical history consistent with either excessive noise exposure or idiopathic sudden sensorineural hearing loss.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Adults aged 18-65 years inclusive.
•2. Established diagnosis of stable sensorineural hearing loss by standard audiometric measures for ≥ 6 months prior to the Screening visit (no changes in air conduction greater than 10 dB at a single frequency or greater than 5 dB at two contiguous frequencies from the prior audiogram to the Screening audiogram in the study ear).
•3. Documented medical history consistent with hearing loss being caused by noise exposure or sudden sensorineural hearing loss.
•4. Pure Tone Audiometry (PTA) within 26-70 dB in the ear to be injected.
•5. Female subjects must be of non-childbearing potential or will need to utilize two methods of highly effective contraception during the study participation (e.g. hormonal contraception or an intrauterine device and condoms) or remain abstinent. Male subjects should use condoms with spermicide during the course of the study or remain abstinent. Subjects should not donate sperm or ova during the study period.

Exclusion Criteria

•1. Previous participation in FX-322 clinical trial.
•2. Currently on any medication consisting of valproic acid, valproate sodium, or divalproex sodium.
•3. Perforation of tympanic membrane or other tympanic membrane disorders that would interfere with the delivery and safety assessment of an intratympanic medication or reasonably be suspected to affect tympanic membrane healing after injection in study ear. This includes a current tympanostomy tube.
•4. Any conductive hearing loss of greater than 15 dB at a single frequency or greater than 10 dB at two or more contiguous octave frequencies in the study ear at the Screening visit or on the prior audiogram (if the Investigator feels there is not a true conductive hearing loss, the Medical Monitor should be consulted).
•5. Active chronic middle ear disease or a history of major middle ear surgery, as an adult, in the ear to be injected.
•6. Subject has had an intratympanic injection in either ear within 6 months of the screening visit.
•7. History of clinically significant vestibular symptoms at the discretion of the investigator.
•8. History of clinically significant systemic autoimmune disease.
•9. History of head or neck radiation treatment or exposure.
•10. History of platinum-based chemotherapy treatment.
+6 more criteria

Locations (16)

Clinical Trial Site

Fresno, California, United States

Clinical Trial Site

Torrance, California, United States

Clinical Trial Site

Colorado Springs, Colorado, United States

Clinical Trial Site

Boca Raton, Florida, United States

Clinical Trial Site

Sarasota, Florida, United States

Clinical Trial Site

Tampa, Florida, United States

Clinical Trial Site

Louisville, Kentucky, United States

Clinical Trial Site

Omaha, Nebraska, United States

Clinical Trial Site

Amherst, New York, United States

Clinical Trial Site

Matthews, North Carolina, United States

Key Dates

Start Date

October 4, 2019

Primary Completion Date

October 6, 2020

Completion Date

December 17, 2020

Last Updated

April 27, 2023

Enrollment

ACTUAL participants

Conditions

Sensorineural Hearing LossNoise Induced Hearing LossSudden Sensorineural Hearing Loss

Interventions

FX-322 (One Dose)

DRUG

FX-322 (Two Doses)

DRUG

FX-322 (Four Doses)

DRUG

Placebo

DRUG

Auditory Performances With Different Stimulation Depths in Cochlear Implanted Subjects Using a Fine Structure Strategy

NCT04591093

Sensorineural Hearing Loss, Bilateral

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RECRUITING

Vestibular and Postural Function in an Unselected Group of Children With Sensorineural Hearing Loss

NCT06229717

Children, OnlyVestibular Disorder+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 27, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

FX-322 in Adults With Stable Sensorineural Hearing Loss

Inclusion Criteria

Exclusion Criteria

Auditory Performances With Different Stimulation Depths in Cochlear Implanted Subjects Using a Fine Structure Strategy

Vestibular and Postural Function in an Unselected Group of Children With Sensorineural Hearing Loss

Perceptual Adaptation Following Cochlear Implantation (Aim 3a)

Natural History in Children Up to 16 Years with Mild to Profound Hearing Loss Due to Mutations in GJB2 / OTOF Genes

Healthy heaAring for Healthy Ageing: Data-driven Hearing Rehabilitation Intervention to Promote Healthy Hearing

Optimizing Cochlear Implant Laterality in Patients With Unilateral Vestibular Weakness