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

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

Timeline

Start

2019-02-15

Primary completion

2021-11-04

Completion

2022-01-12

Outcome

Missed primary endpoint

registry analysis (superiority test); 29 mg Dose Group vs Placebo Oral Tablet; p = 0.3419; Mixed Models Analysis NCT03603314 ↗

registry analysis (superiority test); 43.5 mg Dose Group vs Placebo Oral Tablet; p = 0.5181; Mixed Models Analysis NCT03603314 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SENS-401	Unknown	29 mg	Oral
Subject	SENS-401	Unknown	43.5 mg	Oral

Indications