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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03908567

Acronym

TRAVERS

Enrollment

124

Registered

2019-04-09

Start date

2019-07-18

Completion date

2022-03-28

Last updated

2023-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vestibular Vertigo

Keywords

Vertigo, Balance

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.

Interventions

DRUGIntranasal Drug

Intranasal administration of solution with betahistine dihydrochloride; Dosing 3 times a day

DRUGOral Tablet

Oral dosing with tablets 3 times a day

OTHERIntranasal Placebo

Intranasal administration of solution without betahistine dihydrochloride; Dosing 3 times a day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

For intranasal subjects, allocation is blinded. The oral arm is an open-label arm.

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

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.

Design outcomes

Primary

Measure	Time frame	Description
Improvement of time standing on foam (eyes closed)	Day 3 to Day 14	—
Improvement in tandem Romberg test (eyes closed)	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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026