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

NCT03603314 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2023-03-01

Study results available
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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

Conditions

  • Severe Sudden Sensorineural Hearing Loss

Interventions

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

Sponsors & Collaborators

  • Sensorion

    lead INDUSTRY

Principal Investigators

  • Géraldine HONNET, MD · Sensorion

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-15
Primary Completion
2021-11-04
Completion
2022-01-12
FDA Drug
Yes

Countries

  • Bulgaria
  • Canada
  • Czechia
  • France
  • Germany
  • Israel
  • Serbia
  • Slovakia
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03603314 on ClinicalTrials.gov