NCT03908567

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

Multicenter Randomized Controlled Phase 2 Trial to Evaluate AM-125 in the Treatment of Acute Peripheral Vertigo Following Neurosurgery (TRAVERS)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Auris Medical AG · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vestibular Vertigo

Interventions

Type	Name	Description
DRUG	Intranasal Drug	Intranasal administration of solution with betahistine dihydrochloride; Dosing 3 times a day
DRUG	Oral Tablet	Oral dosing with tablets 3 times a day
OTHER	Intranasal Placebo	Intranasal administration of solution without betahistine dihydrochloride; Dosing 3 times a day

Timeline

• Start date: 2019-07-18
• Primary completion: 2022-03-28
• Completion: 2022-03-28
• First posted: 2019-04-09
• Last updated: 2023-09-14

Locations

1 site across 1 country: France