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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04120116
Recruitment Status : Recruiting
First Posted : October 9, 2019
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
Frequency Therapeutics

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sensorineural Hearing Loss Noise Induced Hearing Loss Sudden Sensorineural Hearing Loss Drug: FX-322 Drug: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 4, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: FX-322 Single Dose, Placebo Three Doses
Four intratympanic injections of a hydrogel formulation
 Drug: FX-322
Dosing occurs once weekly for four consecutive weeks. Patients will receive one, two or four doses of FX-322, followed by three, two or zero Placebo doses, respectively.

Drug: Placebo
Dosing occurs once weekly for four consecutive weeks. Patients will receive two, three or four doses of Placebo, preceded by two, one or zero Placebo doses, respectively.
Experimental: FX-322 Two Doses, Placebo Two Doses
Four intratympanic injections of a hydrogel formulation
 Drug: FX-322
Dosing occurs once weekly for four consecutive weeks. Patients will receive one, two or four doses of FX-322, followed by three, two or zero Placebo doses, respectively.

Drug: Placebo
Dosing occurs once weekly for four consecutive weeks. Patients will receive two, three or four doses of Placebo, preceded by two, one or zero Placebo doses, respectively.
Experimental: FX-322 Four Doses
Four intratympanic injections of a hydrogel formulation
 Drug: FX-322
Dosing occurs once weekly for four consecutive weeks. Patients will receive one, two or four doses of FX-322, followed by three, two or zero Placebo doses, respectively.
Placebo Comparator: Placebo Four Doses
Four intratympanic injections of a hydrogel formulation
 Drug: Placebo
Dosing occurs once weekly for four consecutive weeks. Patients will receive two, three or four doses of Placebo, preceded by two, one or zero Placebo doses, respectively.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Speech Intelligibility [ Time Frame: Screening to Day 210 ]
    Speech intelligibility using the Words-in-Noise test measured with Consonant-Nucleus-Consonant (CNC) word lists

  3. 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)

  4. 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

  5. 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.

  6. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adults aged 18-65 years inclusive.
  2. Established diagnosis of sensorineural hearing loss by standard audiometric measures that is stable for ≥ 6 months prior to the Screening Visit [no changes greater than 5 decibels (dB) in any frequency].
  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 10 dB or more at two or more frequencies in either ear.
  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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04120116


Contacts
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Contact: Clinical Trials Information Desk 800-839-9241 ClinicalTrialsInformation@FrequencyTx.com

Locations
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United States, California
Clinical Trial Site Recruiting
Fresno, California, United States, 93720
Contact: Clinical Trials Informations Desk    800-839-9241      
Clinical Trial Site Recruiting
Torrance, California, United States, 90503
Contact: Clinical Trial Information Desk    800-839-9241      
United States, Colorado
Clinical Trial Site Recruiting
Colorado Springs, Colorado, United States, 80909
Contact: Clinical Trial Information Desk    800-839-9241      
United States, Florida
Clinical Trial Site Recruiting
Boca Raton, Florida, United States, 33487
Contact: Clinical Trial Information Desk    800-839-9241      
Clinical Trial Site Recruiting
Sarasota, Florida, United States, 34239
Contact: Clinical Trials Information Desk    800-839-9241      
Clinical Trial Site Recruiting
Tampa, Florida, United States, 33612
Contact: Clinical Trial Information Desk    800-839-9241      
United States, Kentucky
Clinical Trial Site Recruiting
Louisville, Kentucky, United States, 40207
Contact: Clinical Trials Information Desk    800-839-9241      
United States, Nebraska
Clinical Trial Site Recruiting
Omaha, Nebraska, United States, 68118
Contact: Clinical Trial Information Desk    800-839-9241      
United States, North Carolina
Clinical Trial Site Recruiting
Matthews, North Carolina, United States, 28105
Contact: Clinical Trial Information Desk    800-839-9241      
Clinical Trial Site Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Clinical Trial Information Desk    800-839-9241      
United States, South Carolina
Clinical Trial Site Recruiting
Orangeburg, South Carolina, United States, 29118
Contact: Clinical Trials Information Desk    800-839-9241      
United States, Texas
Clinical Trial Site Recruiting
San Antonio, Texas, United States, 78240
Contact: Clinical Trial Information Desk    800-839-9241      
Sponsors and Collaborators
Frequency Therapeutics
Investigators
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Study Director: Carl LeBel, PhD Frequency Therapeutics
More Information
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Responsible Party: Frequency Therapeutics
ClinicalTrials.gov Identifier: NCT04120116    
Other Study ID Numbers: FX-322-202
First Posted: October 9, 2019    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Frequency Therapeutics:
Intratympanic Administration
Restoration of Hearing Function
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Loss, Noise-Induced
Hearing Disorders
Ear Diseases
 Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms