Efficacy of SENS 401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss (AUDIBLE-S)

• ClinicalTrials.gov Identifier: NCT03603314
• Recruitment Status: Completed
• First Posted: July 27, 2018
• Last Update Posted: January 31, 2022
• Sponsor: Sensorion
• Information provided by (Responsible Party): Sensorion

Study Description

Brief Summary:

Primary objective of the study is to assess the efficacy of SENS-401 on hearing loss in comparison to placebo at the end of the 4-week treatment period

Condition or disease	Intervention/treatment	Phase
Severe Sudden Sensorineural Hearing Loss	Drug: SENS-401; Other: Placebo Oral Tablet	Phase 2; Phase 3

Detailed Description:

Patients will receive the study drug (SENS-401 or placebo) in the form of tablets by mouth, twice a day (3 tablets in the morning and 3 tablets in the evening), during the first 4 weeks after randomization.

SENS-401 is an investigational medicinal product. It belongs to a family of drugs known as "5 HT3 antagonist".

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 115 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Two-part, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy and Safety Study of SENS-401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss
• Actual Study Start Date: February 15, 2019
• Actual Primary Completion Date: November 4, 2021
• Actual Study Completion Date: January 12, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: 29 mg dose group; Patients will receive the study drug (SENS-401) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization.	Drug: SENS-401; 29 mg dose group: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks
Experimental: 43.5 mg dose group; Patients will receive the study drug (SENS-401) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization.	Drug: SENS-401; 43.5 mg dose groupe: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks
Placebo Comparator: placebo oral tablet; Patients will receive the study drug (placebo) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization.	Other: Placebo Oral Tablet; placebo, oral route, by mouth, twice a day, during 4 weeks

Outcome Measures

Primary Outcome Measures :

1. Change in pure tone audiometry PTA (dB) [ Time Frame: 28 days ]
   Change in pure tone audiometry PTA (dB) in affected ear from baseline to the end of treatment visit

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

The main criteria for inclusion:

• Male or female aged at least 18 years old
• Patients with unilateral idiopathic sudden sensorineural hearing loss or unilateral/bilateral acute acoustic trauma leading to sudden sensorineural hearing loss.
• Patients with sudden hearing loss with onset within 96 hours prior to prior to first study drug intake.
• Patients under highly effective contraception

The main criteria for exclusion:

• Bilateral idiopathic hearing loss
• Fluctuating hearing loss
• History of asymmetric hearing (>20 dB difference between ears) to the best knowledge of the patient
• Severe hearing loss (>90 dB) associated with unilateral (ipsilateral) complete vestibular loss.
• History of Ménière's disease, autoimmune hearing loss, radiation-induced hearing loss, acoustic neuroma (schwannoma), otosclerosis, suspected perilymph fistula or membrane rupture, suspected retro-cochlear lesion, or barotrauma
• Previous SSNHL in the affected ear within the past 6 weeks
• Complete loss of peripheral vestibular function on the affected side
• Any drug-based therapy for inner ear hearing loss that is ongoing or was performed in the past 6 weeks (except oral corticosteroids)
• Any ongoing or planned concomitant medication for the treatment of tinnitus until 6 weeks after administration.
• Any therapy known as ototoxic (e.g. aminoglycosides, cisplatin, loop diuretics, quinine etc.) at the current time or in the past 6 months or planned in the coming 3 months.
• Acute or chronic otitis media or otitis externa terminated less than 7 days
• Prior ear surgery of any kind (except ventilating tubes), or cochlear implants
• Known history of, or concomitant severe hepatic, gastrointestinal, cardiovascular, respiratory, neurological (except vertigo or tinnitus), hematological, renal, dermatological or psychiatric disease or substance abuse
• Neurological disorders including stroke, demyelinating disease, brain stem or cerebellar dysfunction within the last 3 months.
• Treatment with any investigational agent within 4 weeks or any past treatment with azasetron or with 5-HT3 antagonists, or any prior or planned treatment by antidepressant treatment containing serotoninergic agents.
• Patients with either a history of significant arrhythmia, or a history of conditions known to increase the proarrhythmic risk (e.g., congestive heart failure, long QT Syndrome, hypokalemia etc...).

Contacts and Locations

Locations

France

Hôpital Lariboisière

Paris, France, 75010

Sponsors and Collaborators

Sensorion

Investigators

• Study Director: Géraldine HONNET, MD; Sensorion

More Information

• Responsible Party: Sensorion
• ClinicalTrials.gov Identifier: NCT03603314
• Other Study ID Numbers: SENS 401-201
• First Posted: July 27, 2018
• Last Update Posted: January 31, 2022
• Last Verified: January 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Hearing Loss; Deafness; Hearing Loss, Sensorineural; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases