Efficacy of SENS 401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss

Brief Title

Efficacy of SENS 401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss

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

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
    

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 Phase

Phase 2/Phase 3

Study Type

Interventional

Primary Outcome

Change in pure tone audiometry PTA (dB)

Condition

Severe Sudden Sensorineural Hearing Loss

Intervention

SENS-401

Study Arms / Comparison Groups

 29 mg dose group

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

458

Start Date

February 15, 2019

Completion Date

August 30, 2022

Primary Completion Date

June 30, 2021

Eligibility 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...).
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Géraldine HONNET, MD, +33(0)786676542, [email protected]

Location Countries

France

Location Countries

France

NCT ID

NCT03603314

Organization ID

SENS 401-201

Responsible Party

Sponsor

Study Sponsor

Sensorion

Study Sponsor

Géraldine HONNET, MD, Study Director, Sensorion

Verification Date

October 2020