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

Primary Purpose

Vestibular Vertigo

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Intranasal Drug
Oral Tablet
Intranasal Placebo
Sponsored by
Auris Medical AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vestibular Vertigo focused on measuring Vertigo, Balance

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHP Clairval

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo

1 mg AM-125

10 mg AM-125

20 mg AM-125

Oral 16 mg betahistine

Arm Description

Nasal spray solution without active ingredient

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.

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.

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.

Tablets containing betahistine dihydrochloride. Administered three times daily as 1 tablet per time. Total daily dose is 48 mg oral betahistine dihydrochloride.

Outcomes

Primary Outcome Measures

Improvement of time standing on foam (eyes closed)
Improvement in tandem Romberg test (eyes closed)
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.

Secondary Outcome Measures

Full Information

First Posted
April 5, 2019
Last Updated
September 13, 2023
Sponsor
Auris Medical AG
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1. Study Identification

Unique Protocol Identification Number
NCT03908567
Brief Title
AM-125 in the Treatment of Acute Peripheral Vertigo Following Neurosurgery
Acronym
TRAVERS
Official Title
Multicenter Randomized Controlled Phase 2 Trial to Evaluate AM-125 in the Treatment of Acute Peripheral Vertigo Following Neurosurgery (TRAVERS)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 18, 2019 (Actual)
Primary Completion Date
March 28, 2022 (Actual)
Study Completion Date
March 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Auris Medical AG

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Vertigo
Keywords
Vertigo, Balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
For intranasal subjects, allocation is blinded. The oral arm is an open-label arm.
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Nasal spray solution without active ingredient
Arm Title
1 mg AM-125
Arm Type
Experimental
Arm Description
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.
Arm Title
10 mg AM-125
Arm Type
Experimental
Arm Description
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.
Arm Title
20 mg AM-125
Arm Type
Experimental
Arm Description
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.
Arm Title
Oral 16 mg betahistine
Arm Type
Experimental
Arm Description
Tablets containing betahistine dihydrochloride. Administered three times daily as 1 tablet per time. Total daily dose is 48 mg oral betahistine dihydrochloride.
Intervention Type
Drug
Intervention Name(s)
Intranasal Drug
Intervention Description
Intranasal administration of solution with betahistine dihydrochloride; Dosing 3 times a day
Intervention Type
Drug
Intervention Name(s)
Oral Tablet
Intervention Description
Oral dosing with tablets 3 times a day
Intervention Type
Other
Intervention Name(s)
Intranasal Placebo
Intervention Description
Intranasal administration of solution without betahistine dihydrochloride; Dosing 3 times a day
Primary Outcome Measure Information:
Title
Improvement of time standing on foam (eyes closed)
Time Frame
Day 3 to Day 14
Title
Improvement in tandem Romberg test (eyes closed)
Description
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.
Time Frame
Day 3 to Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: Scheduled for neurosurgery (vestibular schwannoma resection, labyrinthectomy or vestibular neurectomy). 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. Confirmed vestibular function on both sides. Main Exclusion Criteria: Prior radiotherapy (gammaknife, intensity modulated radiation therapy) irradiating the brain-stem with more than 4 Gy. 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). Vestibular rehabilitation therapy or presurgical gentamicin therapy (i.e. "pre-habilitation therapy") within the past three months prior neurosurgery. Any clinically relevant nasal obstruction or pathology precluding effective and/or safe intranasal delivery.
Facility Information:
Facility Name
CHP Clairval
City
Marseille
Country
France

12. IPD Sharing Statement

Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-002474-52/results
Description
Link to Result entry in clinicaltrialsregister.eu
URL
https://pubmed.ncbi.nlm.nih.gov/37026797/
Description
Link to peer-reviewed publication of study

Learn more about this trial

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

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