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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03603314
Recruitment Status : Completed
First Posted : July 27, 2018
Last Update Posted : January 31, 2022
Sponsor:
Information provided by (Responsible Party):
Sensorion

Tracking Information
First Submitted Date  ICMJE July 5, 2018
First Posted Date  ICMJE July 27, 2018
Last Update Posted Date January 31, 2022
Actual Study Start Date  ICMJE February 15, 2019
Actual Primary Completion Date November 4, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of SENS 401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Severe Sudden Sensorineural Hearing Loss
Intervention  ICMJE
  • Drug: SENS-401
    29 mg dose group: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks
  • Other: Placebo Oral Tablet
    placebo, oral route, by mouth, twice a day, during 4 weeks
  • Drug: SENS-401
    43.5 mg dose groupe: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks
Study Arms  ICMJE
  • 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.
    Intervention: Drug: SENS-401
  • 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.
    Intervention: Drug: SENS-401
  • 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.
    Intervention: Other: Placebo Oral Tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 28, 2022)
115
Original Estimated Enrollment  ICMJE
 (submitted: July 26, 2018)
458
Actual Study Completion Date  ICMJE January 12, 2022
Actual Primary Completion Date November 4, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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...).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03603314
Other Study ID Numbers  ICMJE SENS 401-201
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sensorion
Study Sponsor  ICMJE Sensorion
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Géraldine HONNET, MD Sensorion
PRS Account Sensorion
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP