Efficacy of SENS-111 in Patients Suffering From Acute Unilateral Vestibulopathy

Summary

A multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of 2 dose-regimens of orally administered SENS-111 (100mg and 200mg) given during 4 days in patients suffering from Acute Unilateral Vestibulopathy (AUV)

Timeline

Start

2017-08-16

Primary completion

2019-10-15

Completion

2019-10-15

Outcome

Missed primary endpoint

registry analysis (superiority test); SENS-111 100mg vs SENS-111 200mg vs Placebo; p = 0.8466; ANCOVA NCT03110458 ↗

release “SENS-111 était sûr et bien toléré par les 105 patients lors de l’étude ; le critère d’évaluation principal n’a pas été atteint” sensorion.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SENS-111	Unknown	100 mg	Oral
Subject	SENS-111	Unknown	200 mg	Oral

Indications