FX-322 in Adults With Stable Sensorineural Hearing Loss (NCT04120116) | Clinical Trial Compass
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 range18 Years – 65 Years
SexALL
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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.
✕. 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).
What they're measuring
1
Word Recognition in Quiet
Timeframe: Baseline to Day 210
2
Words-in-Noise
Timeframe: Baseline to Day 210
3
Pure Tone Audiometry
Timeframe: Baseline to Day 210
4
Treatment-emergent Adverse Events (TEAEs)
Timeframe: Baseline to Day 210
5
Otoscopy Abnormalities
Timeframe: Baseline and Days 8, 15, 21 60, 90,150, and 210