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Trial record 2 of 2 for:    SENS-401

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

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ClinicalTrials.gov Identifier: NCT03603314
Recruitment Status : Not yet recruiting
First Posted : July 27, 2018
Last Update Posted : July 27, 2018
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".


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
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : August 2020


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

Inclusion Criteria:

  • Male or female
  • Over 18 years old
  • Patients with unilateral sudden sensorineural hearing loss

Exclusion Criteria:

  • Bilateral hearing loss
  • History of Meniere's disease, autoimmune hearing loss, radiation-induced hearing loss, acoustic neuroma.

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
Contact: Mélina BLAIRVACQ, CRA +33 4 34 08 71 17 melina.blairvacq@sensorion-pharma.com

Sponsors and Collaborators
Sensorion
Investigators
Study Director: Judith LAREDO, PhD Sensorion

Responsible Party: Sensorion
ClinicalTrials.gov Identifier: NCT03603314     History of Changes
Other Study ID Numbers: SENS 401-201
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: July 2018

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
Signs and Symptoms