drugset / Trial / NCT03908567

AM-125 in the Treatment of Acute Peripheral Vertigo Following Neurosurgery

NCT03908567

Phase 2 Completed 124 enrolled Auris Medical AG
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Treatment of vertigo after removal of a tumor of the balance and hearing nerve after neurosurgery, which damages or cuts the vestibular nerve (balance). This trial explores the efficacy and safety of AM-125 in the treatment of acute vertigo. In this proof of concept trial patients experiencing vertigo after neurosurgery (vestibular schwannoma labyrinthectomy and vestibular neurectomy) will receive AM-125 or placebo. It evaluates the potential of AM-125 versus placebo in reducing the symptoms of vestibular dysfunction and accelerating vestibular compensation following neurosurgery.

Timeline

Start
2019-07-18
Primary completion
2022-03-28
Completion
2022-03-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Betahistine Small molecule 1 mg Intranasal
Subject Betahistine Small molecule 10 mg Intranasal
Subject Betahistine Small molecule 16 mg Intranasal
Subject Betahistine Small molecule 20 mg Intranasal

Indications