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FX-322 in Adults With Stable Sensorineural Hearing Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04120116
Recruitment Status : Completed
First Posted : October 9, 2019
Last Update Posted : October 20, 2021
Sponsor:
Information provided by (Responsible Party):
Frequency Therapeutics

Tracking Information
First Submitted Date  ICMJE September 30, 2019
First Posted Date  ICMJE October 9, 2019
Last Update Posted Date October 20, 2021
Actual Study Start Date  ICMJE October 4, 2019
Actual Primary Completion Date October 6, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2021)
  • Speech Intelligibility - Word Recognition in Quiet [ Time Frame: Screening to Day 210 ]
    Assessment of speech intelligibility using the Word Recognition in Quiet test measured with Consonant-Nucleus-Consonant (CNC) word lists.
  • Speech Intelligibility - Words-in-Noise [ Time Frame: Screening to Day 210 ]
    Speech intelligibility using the Words-in-Noise test measured with Consonant-Nucleus-Consonant (CNC) word lists
  • Standard Pure Tone Audiometry [ Time Frame: Screening to Day 210 ]
    Standard pure tone audiometry will be measured to determine a subject's threshold for hearing at standard frequencies (Hz)
  • Systemic Safety: Number of patients with treatment-related adverse events [ Time Frame: Screening to Day 210 ]
    Number of patients with treatment-related adverse events assessed by CTCAE v5.0
  • Local Safety: Number of patients with abnormal changes from baseline in otoscopic examinations [ Time Frame: Screening to Day 210 ]
    Microscopic otoscopy will be included to specifically record any abnormalities of the external ear canal, tympanic membrane and middle ear.
  • Local Safety: The number of patients with abnormal changes from baseline in tympanometry [ Time Frame: Screening to Day 210 ]
    Tympanometry tests the integrity of the tympanic membrane by varying air pressure in the ear canal. Middle ear compliance (mL), peak pressure (daPa), and ear canal volume (mL) will be recorded.
Original Primary Outcome Measures  ICMJE
 (submitted: October 8, 2019)
  • Speech Intelligibility [ Time Frame: Screening to Day 210 ]
    Assessment of speech intelligibility using the Word Recognition in Quiet test measured with Consonant-Nucleus-Consonant (CNC) word lists.
  • Speech Intelligibility [ Time Frame: Screening to Day 210 ]
    Speech intelligibility using the Words-in-Noise test measured with Consonant-Nucleus-Consonant (CNC) word lists
  • Standard Pure Tone Audiometry [ Time Frame: Screening to Day 210 ]
    Standard pure tone audiometry will be measured to determine a subject's threshold for hearing at standard frequencies (Hz)
  • Systemic Safety: Number of patients with treatment-related adverse events [ Time Frame: Screening to Day 210 ]
    Number of patients with treatment-related adverse events assessed by CTCAE v5.0
  • Local Safety: Number of patients with abnormal changes from baseline in otoscopic examinations [ Time Frame: Screening to Day 210 ]
    Microscopic otoscopy will be included to specifically record any abnormalities of the external ear canal, tympanic membrane and middle ear.
  • Local Safety: The number of patients with abnormal changes from baseline in tympanometry [ Time Frame: Screening to Day 210 ]
    Tympanometry tests the integrity of the tympanic membrane by varying air pressure in the ear canal. Middle ear compliance (mL), peak pressure (daPa), and ear canal volume (mL) will be recorded.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2019)
  • 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)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FX-322 in Adults With Stable Sensorineural Hearing Loss
Official Title  ICMJE 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
Brief 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Sensorineural Hearing Loss
  • Noise Induced Hearing Loss
  • Sudden Sensorineural Hearing Loss
Intervention  ICMJE
  • Drug: FX-322 (One Dose)
    Patients will receive one dose of FX-322.
  • Drug: FX-322 (Two Doses)
    Patients will receive two doses of FX-322.
  • Drug: FX-322 (Four Doses)
    Patients will receive four doses of FX-322.
  • Drug: Placebo
    Patients will receive Placebo.
Study Arms  ICMJE
  • Experimental: FX-322 Single Dose, Placebo Three Doses
    Four intratympanic injections of a hydrogel formulation, FX-322 Single Dose, Placebo Three Doses.
    Interventions:
    • Drug: FX-322 (One Dose)
    • Drug: Placebo
  • Experimental: FX-322 Two Doses, Placebo Two Doses
    Four intratympanic injections of a hydrogel formulation, FX-322 Two Doses, Placebo Two Doses.
    Interventions:
    • Drug: FX-322 (Two Doses)
    • Drug: Placebo
  • Experimental: FX-322 Four Doses
    Four intratympanic injections of a hydrogel formulation, FX-322 Four Doses.
    Intervention: Drug: FX-322 (Four Doses)
  • Placebo Comparator: Placebo Four Doses
    Four intratympanic injections of a hydrogel formulation, Placebo Four Doses.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 7, 2020)
95
Original Estimated Enrollment  ICMJE
 (submitted: October 8, 2019)
96
Actual Study Completion Date  ICMJE December 17, 2020
Actual Primary Completion Date October 6, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04120116
Other Study ID Numbers  ICMJE FX-322-202
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Frequency Therapeutics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Frequency Therapeutics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Carl LeBel, PhD Frequency Therapeutics
PRS Account Frequency Therapeutics
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP