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

        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.
      

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

May 2020