NCT03603314

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Sensorion · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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".

Conditions

• Severe Sudden Sensorineural Hearing Loss

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-02-15
• Primary completion: 2021-11-04
• Completion: 2022-01-12
• First posted: 2018-07-27
• Last updated: 2023-03-01
• Results posted: 2023-03-01

Locations

26 sites across 10 countries: Bulgaria, Canada, Czechia, France, Germany, Israel, Serbia, Slovakia, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study