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

NCT03908567 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2023-09-14

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Auris Medical AG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03908567 on ClinicalTrials.gov