A study to evaluate the use of SENS-401 in subjects with sudden deafness

Phase 1

Conditions: Sudden sensorineural hearing loss (SSNHL)
MedDRA version: 20.0Level: LLTClassification code 10040016Term: Sensorineural hearing lossSystem Organ Class: 100000004854
Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

Registration Number: EUCTR2018-000812-47-BG

Lead Sponsor: SENSORION SA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 301

Inclusion Criteria

1 Male or female
2 Aged at least 18 years old
3 Patients with unilateral idiopathic sudden sensorineural hearing loss or unilateral/bilateral acute acoustic trauma leading to sudden
sensorineural hearing loss defined by both
• 3.1. At least 1 hearing threshold of 50 dB or more amongst the 3 most affected contiguous frequencies on pure tone audiometric air conduction
testing performed 24 hours or less prior to first study treatment,
and
• 3.2. Mean hearing loss of 30 dB or more, averaged across the air conducted PTA frequencies (pure tone audiometry”, PTA performed 24 hours or less prior to first study treatment), compared with the unaffected contralateral ear or reference values from a pre-existing audiogram (dated less than 2 years) or ISO 7029:2017 norm values in case of asymmetric hearing prior to the ISSNHL incident
4 Patients with sudden hearing loss with onset within 96 hours prior to first study drug intake.
5 Females must meet one of the following: postmenopausal defined as 12 consecutive months with no menses without an alternative medical cause, surgically sterile, abstinent; or practicing highly effective birth control (must agree to use 2 forms of contraception [1 of which must be a barrier method]) (Appendix 4) and willing to continue to use highly effective contraception for the duration of study participation and for 30 days after the final dose of study drug). Women of childbearing potential must have a negative pregnancy test at screening before the first dose of study drug is taken. Women of childbearing potential are defined as any female who has experienced menarche and who is not permanently sterile or postmenopausal.
6 Male subjects and their female partner(s) must agree to use highly effective contraception (must agree to use 2 forms of contraception [1 of which must be a barrier method]) (Appendix 4) for the duration of study participation and for 90 days after the final dose of study drug.
7 Signed and dated written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 181
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

1.Bilateral idiopathic hearing loss
2.Fluctuating hearing loss
3.History of asymetric hearing (>20dB difference between ears) to the best knowledge of the patient
4.Severe hearing loss (>90 dB) associated with unilateral (ipsilateral) complete vestibular loss
5.History of Ménière’s disease, autoimmune hearing loss, radiation-induced hearing loss, acoustic neuroma (schwannoma)
6.Previous SSNHL in the affected ear within the past 6 weeks
7.History of otosclerosis, suspected perilymph fistula or membrane rupture, suspected retro-cochlear lesion, barotrauma
8.Congenital or hereditary hearing loss
9. History of severe head or neck trauma
10. Complete loss of peripheral vestibular function on the affected side
11. Any drug-based therapy for inner ear hearing loss that is ongoing or
was performed in the past 6 weeks, except oral corticosteroids
12. Any ongoing or planned concomitant medication for the treatment
of tinnitus until 6 weeks after administration
13. Any therapy known as ototoxic (e.g. aminoglycosides, cisplatin,
loop diuretics, quinine etc.) at the current time or in the past 6 months
prior to study inclusion
14. Air-bone gap of greater than 20 dB in 3 contiguous frequencies
15. Acute chronic otitis media or otitis externa terminated less than 7
days prior to randomisation.
16. History of chronic inflammatory or suppurative ear disease or
cholesteatoma,
17. Prior ear surgery of any kind (except ventilating tubes), or cochlear
implants
18. Patients with moderate to severe renal impairment defined by a
creatinine clearance = 60 ml/min (calculated with the Cockroft-Gault
formula (for patients < 65 years old and with CKD-EPI creatinine equation or with MDRD equation for patients = 65 years old.)
19. Treatment with triptans within the 24 hours before inclusion.
20. History of drug abuse or alcoholism within the last 2 years
21. Known or suspected ongoing active infection of HIV, Hepatitis B or
C, or herpes zoster
22. Known history of, or concomitant severe hepatic, gastrointestinal,
cardiovascular, respiratory, neurological (except vertigo or tinnitus),
hematological, renal, dermatological or psychiatric disease or substance
abuse or any condition that, in the opinion of the Investigator might
interfere with the evaluation of study treatment or warrant exclusion (see list of discontinuation criteria, section 11.3.2)
23. Patients who, in the opinion of the Investigator, have any clinically
relevant findings that warrant exclusion. Examples of clinically relevant
problems include, but are not limited to, serious non-malignancyassociated
medical conditions that may be expected to limit life
expectancy or significantly increase the risk of SAEs and any condition,
psychiatric, substance abuse, or otherwise, that, in the opinion of the
Investigator, would preclude informed consent, consistent follow-up, or
compliance with any aspect of the study
24. Neurological disorders including stroke, demyelinating disease,
brain stem or cerebellar dysfunction within the last 3 months. (In case
of possible stroke of the brainstem or cerebellum, or demyelinating
disease the diagnosis should have been excluded by a MRI performed in
the past 48 hours)
25. Known hypersensitivity, allergy or intolerance to the study
medication or any history of severe abnormal drug reaction
26. Pregnant or breast-feeding
27. Mentally unable to understand the nature, objectives and possible
consequences of the trial, or r

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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