At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 115 enrolled
Drug / intervention
SENS-401 +2 moredrug
Likely dose
SENS-401 29 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating SENS-401 and Placebo Oral Tablet for Severe Sudden Sensorineural Hearing Loss. Completed, enrolled 115 participants across 26 sites in 10 countries.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Sudden Sensorineural Hearing Loss
CountriesBulgaria, Canada, Czechia, France, Germany, Israel, Serbia, Slovakia, Turkey (Türkiye), United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJul 2018
Enrollment StartFeb 2019
Primary CompletionNov 2021
Study CompletionJan 2022
TodayJul 2026
First PostedJul 27, 2018
Enrollment StartFeb 15, 2019
Primary CompletionNov 4, 2021
Study CompletionJan 12, 2022
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 7.9 years ago
Interventions
SENS-401drug
29 mg dose group: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks
Placebo Oral Tabletother
placebo, oral route, by mouth, twice a day, during 4 weeks
SENS-401drug
43.5 mg dose groupe: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks