drugset
drugset / Trial / NCT02809118

Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment

NCT02809118 ↗

Phase 3 Terminated 56 enrolled Auris Medical AG
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of the trial is the confirmation of the efficacy of AM-111 in the recovery of severe to profound idiopathic sudden sensorineural hearing loss (ISSNHL).

Timeline

Start
2016-06
Primary completion
2018-02
Completion
2018-02

Outcome

Outcome not reported

Stopped: “Availability of relevant new efficacy data from another study”

Drugs

EvaluationDrugModalityDoseRoute
Subject BRIMAPITIDE, C-TERMINAL ACID Protein / enzyme biologic 0.4 mg/ml Other
Subject BRIMAPITIDE, C-TERMINAL ACID Protein / enzyme biologic 0.8 mg/ml Other

Indications

sudden sensorineural hearing loss