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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03603314
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : November 2, 2020
Sponsor:
Information provided by (Responsible Party):
Sensorion

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".

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 458 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
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : August 30, 2022


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




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



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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...).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03603314


Contacts
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Contact: Sandrine MEUNIER, MSc +33(0)786676542 SENS-401@sensorion-pharma.com
Contact: Judith LAREDO, PhD SENS-401@sensorion-pharma.com

Locations
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France
Hôpital Lariboisière Recruiting
Paris, France, 75010
Contact: Charlotte Hautefort, MD         
Sponsors and Collaborators
Sensorion
Investigators
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Study Director: Géraldine HONNET, MD Sensorion
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Responsible Party: Sensorion
ClinicalTrials.gov Identifier: NCT03603314    
Other Study ID Numbers: SENS 401-201
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: November 2, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases