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

Phase 2 & 3
Waitlist Available
Research Sponsored by Sensorion
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 84

Summary

This trial tests if SENS-401 can help people with hearing loss by blocking specific brain signals. Participants will take the drug as tablets for a period of time. SENS-401 has previously been shown to improve hearing loss caused by loud noise and reduce hearing loss in animal studies.

Eligible Conditions
  • Sudden Deafness

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 84
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 84 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Pure Tone Audiometry PTA (dB) (Average of the Hearing Threshold of the 3 Contiguous Most Affected Hearing Frequencies in dB as Identified at Study Entry) From Baseline to the End of Treatment Visit (Day 28 ± 3).
Secondary study objectives
Change in Pure Tone Audiometry PTA (dB) (Average of the Hearing Threshold of the 2 Most Affected Hearing Frequencies in dB as Identified at Study Entry) From Baseline to the End of Treatment Visit (Day 28 ± 3).
Change in Pure Tone Audiometry PTA (dB) (Average of the Hearing Threshold of the 3 Most Affected Hearing Frequencies in dB as Identified at Study Entry) From Baseline to the End of Study Visit (Day 84 ± 3).
Change in Pure Tone Audiometry PTA (dB) (the Most Affected Hearing Frequencies in dB as Identified at Study Entry) From Baseline to the End of Treatment Visit (Day 28 ± 3).
+2 more

Side effects data

From 2022 Phase 2 & 3 trial • 115 Patients • NCT03603314
15%
Constipation
15%
Headache
5%
COVID-19
5%
Nausea
3%
colon neoplasm
3%
Vomiting
3%
Vertigo
100%
80%
60%
40%
20%
0%
Study treatment Arm
43.5 mg Dose Group
29 mg Dose Group
Placebo Oral Tablet

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: 43.5 mg dose groupExperimental Treatment1 Intervention
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.
Group II: 29 mg dose groupExperimental Treatment1 Intervention
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.
Group III: placebo oral tabletPlacebo Group1 Intervention
Patients will receive the study drug (placebo) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SENS-401
2019
Completed Phase 3
~160

Find a Location

Who is running the clinical trial?

SensorionLead Sponsor
7 Previous Clinical Trials
521 Total Patients Enrolled
Géraldine HONNET, MDStudy DirectorSensorion
~17 spots leftby Dec 2025
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