Clinical trial NCT04120116: FX-322 in Adults With Stable Sensorineural Hearing Loss
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sensorineural Hearing Loss
Noise Induced Hearing Loss
Sudden Sensorineural Hearing Loss
Keywords: Intratympanic Administration
Restoration of Hearing Function
Lead sponsor: Frequency Therapeutics
Sponsor class: INDUSTRY
First posted: 2019-10-09
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Word Recognition in Quiet
timeFrame: Baseline to Day 210
measure: Words-in-Noise
timeFrame: Baseline to Day 210
measure: Pure Tone Audiometry
timeFrame: Baseline to Day 210
measure: Treatment-emergent Adverse Events (TEAEs)
timeFrame: Baseline to Day 210
measure: Otoscopy Abnormalities
timeFrame: Baseline and Days 8, 15, 21 60, 90,150, and 210
measure: Tympanometry Abnormalities
timeFrame: Baseline and Days 15, 60, 90, 150, 210
Secondary outcomes:
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Clinical Trial Site
state: California
city: Torrance
country: United States
facility: Clinical Trial Site
state: California
city: Colorado Springs
country: United States
facility: Clinical Trial Site
state: Colorado
city: Boca Raton
country: United States
facility: Clinical Trial Site
state: Florida
city: Sarasota
country: United States
facility: Clinical Trial Site
state: Florida
city: Tampa
country: United States
facility: Clinical Trial Site
state: Florida
city: Louisville
country: United States
facility: Clinical Trial Site
state: Kentucky
city: Omaha
country: United States
facility: Clinical Trial Site
state: Nebraska
city: Amherst
country: United States
facility: Clinical Trial Site
state: New York
city: Matthews
country: United States
facility: Clinical Trial Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Clinical Trial Site
state: North Carolina
city: Orangeburg
country: United States
facility: Clinical Trial Site
state: South Carolina
city: Austin
country: United States
facility: Clinical Trial Site
state: Texas
city: San Antonio
country: United States
facility: Clinical Trial Site
state: Texas
city: San Antonio
country: United States
facility: Clinical Trial Site
state: Texas
city: Richmond
country: United States
facility: Clinical Trial Site
state: Virginia
Study officials:
affiliation: Frequency Therapeutics
name: Carl LeBel, PhD
role: STUDY_DIRECTOR
References: