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Completed

NCT Number: NCT03908567

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

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.

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Key information

Conditions

Vestibular Vertigo Ear Diseases Labyrinth Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Vertigo Vestibular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHP Clairval

Marseille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intranasal Drug

Drug

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

Oral Tablet

Drug

Oral dosing with tablets 3 times a day

Intranasal Placebo

Other

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

Primary outcomes

  1. Improvement of time standing on foam (eyes closed)

    Time frame: Day 3 to Day 14

  2. 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.

Sponsors and collaborators

Lead sponsor

Auris Medical AG

Industry

Registry information

Official study title

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

Acronym: TRAVERS

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 9, 2019
Registry last updated
Sep 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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