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

September 13, 2023 updated by: Auris Medical AG

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France
        • CHP Clairval

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Main Inclusion Criteria:

  1. Scheduled for neurosurgery (vestibular schwannoma resection, labyrinthectomy or vestibular neurectomy).
  2. Small to moderately large vestibular schwannoma (Koos grade I-III; Samii grade T1-T3b; ≤ 30 mm in diameter in cerebellopontine angle) that does not displace the brainstem, documented by magnetic resonance imaging not older than six months or Indication for labyrinthectomy or vestibular neurectomy.
  3. Confirmed vestibular function on both sides.

Main Exclusion Criteria:

  1. Prior radiotherapy (gammaknife, intensity modulated radiation therapy) irradiating the brain-stem with more than 4 Gy.
  2. Any ongoing other peripheral vestibular disorder (e.g. Meniere's disease, benign paroxysmal vertigo, vestibular neuritis) or central vestibular disorder (e.g. vestibular migraine, central vertigo).
  3. Vestibular rehabilitation therapy or presurgical gentamicin therapy (i.e. "pre-habilitation therapy") within the past three months prior neurosurgery.
  4. Any clinically relevant nasal obstruction or pathology precluding effective and/or safe intranasal delivery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Nasal spray solution without active ingredient
Other: Intranasal Placebo
Intranasal administration of solution without betahistine dihydrochloride; Dosing 3 times a day
Experimental: 1 mg AM-125
Nasal spray solution with 5 mg/mL betahistine dihydrochloride. Administered three times daily as 1 spray per nostril. Total daily dose is 3 mg betahistine dihydrochloride.
Drug: Intranasal Drug
Intranasal administration of solution with betahistine dihydrochloride; Dosing 3 times a day
Experimental: 10 mg AM-125
Nasal spray solution with 50 mg/mL betahistine dihydrochloride. Administered three times daily as 1 spray per nostril. Total daily dose is 30 mg betahistine dihydrochloride.
Drug: Intranasal Drug
Intranasal administration of solution with betahistine dihydrochloride; Dosing 3 times a day
Experimental: 20 mg AM-125
Nasal spray solution with 100 mg/mL betahistine dihydrochloride. Administered three times daily as 1 spray per nostril. Total daily dose is 60 mg betahistine dihydrochloride.
Drug: Intranasal Drug
Intranasal administration of solution with betahistine dihydrochloride; Dosing 3 times a day
Experimental: Oral 16 mg betahistine
Tablets containing betahistine dihydrochloride. Administered three times daily as 1 tablet per time. Total daily dose is 48 mg oral betahistine dihydrochloride.
Drug: Oral Tablet
Oral dosing with tablets 3 times a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of time standing on foam (eyes closed)
Time Frame: Day 3 to Day 14
Day 3 to Day 14
Improvement in tandem Romberg test (eyes closed)
Time Frame: Day 3 to Day 14
Participants will be asked to stand straight in tandem stand (heel of one foot touching the toes of the other foot) and duration in this position will be measured.
Day 3 to Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Auris Medical AG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2019

Primary Completion (Actual)

March 28, 2022

Study Completion (Actual)

March 28, 2022

Study Registration Dates

First Submitted

April 5, 2019

First Submitted That Met QC Criteria

April 8, 2019

First Posted (Actual)

April 9, 2019

Study Record Updates

Last Update Posted (Actual)

September 14, 2023

Last Update Submitted That Met QC Criteria

September 13, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AM-125-CL-18-01
  • 2018-002474-52 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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