FX-322 in Adults With Stable Sensorineural Hearing Loss

April 25, 2023 updated by: Frequency Therapeutics

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Fresno, California, United States, 93720
        • Clinical Trial Site
      • Torrance, California, United States, 90503
        • Clinical Trial Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Clinical Trial Site
    • Florida
      • Boca Raton, Florida, United States, 33487
        • Clinical Trial Site
      • Sarasota, Florida, United States, 34239
        • Clinical Trial Site
      • Tampa, Florida, United States, 33612
        • Clinical Trial Site
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Clinical Trial Site
    • Nebraska
      • Omaha, Nebraska, United States, 68118
        • Clinical Trial Site
    • New York
      • Amherst, New York, United States, 14226
        • Clinical Trial Site
    • North Carolina
      • Matthews, North Carolina, United States, 28105
        • Clinical Trial Site
      • Winston-Salem, North Carolina, United States, 27103
        • Clinical Trial Site
    • South Carolina
      • Orangeburg, South Carolina, United States, 29118
        • Clinical Trial Site
    • Texas
      • Austin, Texas, United States, 78705
        • Clinical Trial Site
      • San Antonio, Texas, United States, 78258
        • Clinical Trial Site
      • San Antonio, Texas, United States, 78240
        • Clinical Trial Site
    • Virginia
      • Richmond, Virginia, United States, 23235
        • Clinical Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.
  11. Exposure to another investigational drug within 28 days prior to injection of study drug.
  12. Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator following a detailed medical history, physical examination, and vital signs (systolic and diastolic blood pressure, pulse rate, body temperature).
  13. History of substance abuse within 2 years of the Screening Visit.
  14. Positive test for drugs of abuse at screening.
  15. Positive urine pregnancy test or breast-feeding.
  16. Any known factor, condition or disease that, in the view of the Investigator, might interfere with treatment compliance, study conduct or interpretation of the results (e.g. previous high-dose aminoglycoside treatment).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FX-322 Single Dose, Placebo Three Doses
Four intratympanic injections of a hydrogel formulation, FX-322 Single Dose, Placebo Three Doses.
Patients will receive one dose of FX-322.
Patients will receive Placebo.
Experimental: FX-322 Two Doses, Placebo Two Doses
Four intratympanic injections of a hydrogel formulation, FX-322 Two Doses, Placebo Two Doses.
Patients will receive Placebo.
Patients will receive two doses of FX-322.
Experimental: FX-322 Four Doses
Four intratympanic injections of a hydrogel formulation, FX-322 Four Doses.
Patients will receive four doses of FX-322.
Placebo Comparator: Placebo Four Doses
Four intratympanic injections of a hydrogel formulation, Placebo Four Doses.
Patients will receive Placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Word Recognition in Quiet
Time Frame: Baseline to Day 210
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
Baseline to Day 210
Words-in-Noise
Time Frame: Baseline to Day 210
Mean absolute percent change in number of recognized words from CNC word lists
Baseline to Day 210
Pure Tone Audiometry
Time Frame: Baseline to Day 210
Mean overall pure tone average (PTA) hearing thresholds in decibels (dB) derived by averaging the air conduction thresholds at 0.5, 1, 2 and 4kHZ frequencies
Baseline to Day 210
Treatment-emergent Adverse Events (TEAEs)
Time Frame: Baseline to Day 210
Number of patients with treatment-related adverse events assessed by CTCAE v5.0
Baseline to Day 210
Otoscopy Abnormalities
Time Frame: Baseline and Days 8, 15, 21 60, 90,150, and 210
Number of treated ears with abnormalities of the external ear canal, tympanic membrane and middle ear at each specified time point
Baseline and Days 8, 15, 21 60, 90,150, and 210
Tympanometry Abnormalities
Time Frame: Baseline and Days 15, 60, 90, 150, 210
Number of treated ears with changes in middle ear compliance (mL), peak pressure (daPa), and/or ear canal volume (mL) from baseline
Baseline and Days 15, 60, 90, 150, 210

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extended High Frequency Pure Tone Audiometry
Time Frame: Screening to Day 210
Pure tone audiometry will be measured to determine a subject's threshold for hearing at extended high range frequencies (Hz)
Screening to Day 210
Tinnitus Assessment
Time Frame: Screening to Day 210
Measured by the Tinnitus Functional Index (TFI), with a scale ranging from 0 to 100 that defines severity categories based on 25 self-reported answers.
Screening to Day 210
Hearing Handicap Inventory
Time Frame: Screening to Day 210
The Hearing Handicap Inventory for Adults (HHIA), is a 25-item self-assessment scale composed of two subscales (emotional and social/situational). The subject will self-report one of the following answers for each item on the scale: Yes, Sometimes, No.
Screening to Day 210
Hearing Screening Inventory
Time Frame: Screening to Day 210
The Hearing Screening Inventory (HSI) is a 12 item self report inventory to assess hearing impairment. The subject will self report one of the following answers, for each question from 1 to 8: Never, Seldom, Occasionally, Frequently, Always, and for each question from 9 to 12: Good, Average, Slightly below average, Poor, Very Poor. The HSI is designed to assess subjective change during the study.
Screening to Day 210

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Carl LeBel, PhD, Frequency Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2019

Primary Completion (Actual)

October 6, 2020

Study Completion (Actual)

December 17, 2020

Study Registration Dates

First Submitted

September 30, 2019

First Submitted That Met QC Criteria

October 8, 2019

First Posted (Actual)

October 9, 2019

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 25, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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