CompletedPhase 2

FX-322 in Adults With Stable Sensorineural Hearing Loss

United States95 participantsStarted 2019-10-04

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Adults aged 18-65 years inclusive.
. 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).
. Documented medical history consistent with hearing loss being caused by noise exposure or sudden sensorineural hearing loss.
. Pure Tone Audiometry (PTA) within 26-70 dB in the ear to be injected.
. 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

. Previous participation in FX-322 clinical trial.
. Currently on any medication consisting of valproic acid, valproate sodium, or divalproex sodium.
. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Word Recognition in Quiet

Timeframe: Baseline to Day 210

Words-in-Noise

Timeframe: Baseline to Day 210

Pure Tone Audiometry

Timeframe: Baseline to Day 210

Treatment-emergent Adverse Events (TEAEs)

Timeframe: Baseline to Day 210

Otoscopy Abnormalities

Timeframe: Baseline and Days 8, 15, 21 60, 90,150, and 210

Tympanometry Abnormalities

Timeframe: Baseline and Days 15, 60, 90, 150, 210

Trial details

NCT IDNCT04120116

SponsorFrequency Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-10-06

Results submitted2023-03-30

View on ClinicalTrials.gov More Sensorineural Hearing Loss trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Adults aged 18-65 years inclusive.
. 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).
. Documented medical history consistent with hearing loss being caused by noise exposure or sudden sensorineural hearing loss.
. Pure Tone Audiometry (PTA) within 26-70 dB in the ear to be injected.
. 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

. Previous participation in FX-322 clinical trial.
. Currently on any medication consisting of valproic acid, valproate sodium, or divalproex sodium.
. 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.

What they're measuring

Word Recognition in Quiet

Timeframe: Baseline to Day 210

Words-in-Noise

Timeframe: Baseline to Day 210

Pure Tone Audiometry

Timeframe: Baseline to Day 210

Treatment-emergent Adverse Events (TEAEs)

Timeframe: Baseline to Day 210

Otoscopy Abnormalities

Timeframe: Baseline and Days 8, 15, 21 60, 90,150, and 210

Tympanometry Abnormalities

Timeframe: Baseline and Days 15, 60, 90, 150, 210