Otoferlin Gene-mediated Hearing Loss Natural History Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 44
SponsorAkouos, Inc.
About this trial
This is a retrospective and prospective longitudinal study in participants with Otoferlin Gene-Mediated Hearing Loss.
Eligibility criteria
Qualifiers
Clinical presentation of bilateral sensorineural hearing loss (SNHL), including auditory neuropathy (AN) / auditory neuropathy spectrum disorder (ANSD) phenotype or medical history of AN / ANSD phenotype earlier in life
Mutation(s) in the otoferlin gene
Able and willing to comply with all study requirements, as evidenced by successful completion of the informed consent (and assent, if applicable) process
Presence of OAE / CM and absent / abnormal ABRs in at least one ear (that does not have a cochlear implant) within 12 months prior to or at the Month 0 visit
Disqualifiers
Unwillingness or inability of the potential participant and/or legally authorized representative to comply with all protocol requirements
Presence of cochlear nerve deficiency and/or cochlear nerve dysplasia
Presence of bilateral cochlear implants at the time of record review or planned within the next 6 months
Presence of middle ear or auditory brainstem implant(s) at the time of record review or planned within the next 6 months
Trial design
Treatments tested in this trial
- Natural History Study
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Akouos, Inc.
Lead sponsor
Eli Lilly and Company
Collaborator
Source ClinicalTrials.gov