Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05086276 · ClinicalTrials.gov registry record · Phase 2
FX-322 in Adults With Acquired Sensorineural Hearing Loss
A Phase 2 study of Hearing Loss, Sensorineural and Noise-induced Hearing Loss, sponsored by Frequency Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 142
- Enrollment target
- 20
- Study locations
NCT05086276: Completed Phase 2 study of Hearing Loss, Sensorineural and Noise-induced Hearing Loss, sponsored by Frequency Therapeutics.
NCT05086276 is a Phase 2 study of Hearing Loss, Sensorineural and Noise-induced Hearing Loss that has completed, run by Frequency Therapeutics. The registered enrollment target is 142 participants, below the 779-participant average among 20 other Hearing Loss, Sensorineural trials with a reported enrollment target (82% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05086276, a Phase 2 study of Hearing Loss, Sensorineural and Noise-induced Hearing Loss, has completed, sponsored by Frequency Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 142 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 2, prospective, randomized, double-blind, placebo-controlled, single-dose, multicenter study to evaluate the efficacy of FX-322, administered by intratympanic injection, in adults with acquired sensorineural hearing loss (SNHL).
Primary Outcome
Percent of subjects exceeding the Carney-Schlauch 95% confidence interval for improvement from baseline in number of words recognized from Consonant-Nucleus-Consonant (CNC) word lists
Conditions Studied
Interventions
- DRUG Placebo
- DRUG FX-322
Study Locations (20)
New York
- Clinical Trial Site - Albany
- Clinical Trial Site - Amherst
- Clinical Trial Site - New York
South Carolina
- Clinical Trial Site - Charleston
- Clinical Trial Site - Orangeburg
- Clinical Trial Site - Spartanburg
California
- Clinical Trial Site - Fresno
- Clinical Trial Site - Torrance
Florida
- Clinical Trial Site - Sarasota
- Clinical Trial Site - Tampa
Texas
- Clinical Trial Site - Dallas
- Clinical Trial Site - Fort Worth
Arizona
- Clinical Trial Site - Tucson
Colorado
- Clinical Trial Site - Colorado Springs
Louisiana
- Clinical Trial Site - Marrero
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 142 participants |
| Start Date | 2021-10-12 |
| Est. Completion | 2022-12-30 |
| Phase | Phase 2 |
What the finished NCT05086276 record still lists
NCT05086276 is an interventional study that assigns participants to a tested intervention. The registered 142 participants enrollment target is mid-sized for trials with a published cap, below the 779-participant average among 20 other Hearing Loss, Sensorineural trials with a reported enrollment target (82% lower).
The record links to 3 conditions, with Hearing Loss, Sensorineural appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05086276 names 20 study sites across 13 states, led by New York, South Carolina, California.
Frequently Asked Questions
What is clinical trial NCT05086276 about?
NCT05086276 is a clinical study titled "FX-322 in Adults With Acquired Sensorineural Hearing Loss". This is a Phase 2, prospective, randomized, double-blind, placebo-controlled, single-dose, multicenter study to evaluate the efficacy of FX-322, administered by intratympanic injection, in adults with acquired sensorineural hearing loss (SNHL).
What is the current status of trial NCT05086276?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 142 participants. The study started on 2021-10-12. Estimated completion is 2022-12-30.
What conditions does trial NCT05086276 study?
This clinical trial studies the following conditions: Hearing Loss, Sensorineural, Noise-induced Hearing Loss, Sudden Hearing Loss.
What interventions are being tested in trial NCT05086276?
The interventions under investigation include: Placebo (DRUG), FX-322 (DRUG).
Who is sponsoring clinical trial NCT05086276?
This trial is sponsored by Frequency Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05086276 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hearing Loss, Sensorineural
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05086276's enrollment target sits among peer trials
142 5th of 20 higher than 16 of 20 other Hearing Loss, Sensorineural trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hearing Loss, Sensorineural trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Clinical Utility of Residual Hearing in the Cochlear Implant Ear
RECRUITING · NA
-
Barriers and Facilitators to OTC Hearing Aids Success
RECRUITING · NA
-
Preschool Hearing Screening
RECRUITING · NA
-
Listening Effort in Cochlear Implant Users
RECRUITING · NA
-
Post-Market Clinical Investigation of the IotaSOFT Insertion System
RECRUITING
-
Characterizing Variability in Hearing Aid Outcomes in Among Older Adults With Alzheimer's Dementia
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03933631 · 142 participants · Phase 3
Pilocarpine Use After Kahook Goniotomy
- NCT04938349 · 142 participants · NA
Dual Task Perturbation Training for OAwMCI
- NCT06117254 · 142 participants · NA
Hearing Aids for Veterans With Functional Hearing Difficulties
- NCT06463665 · 142 participants · Phase 2
Efficacy & Safety of Olvimulogene Nanivacirepvec & Platinum-doublet + Physician's Choice of Immune Checkpoint Inhibitor Compared to Docetaxel in NSCL Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI