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

Study Overview
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Brief Summary
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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.

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

Conditions
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Vestibular Vertigo

Intervention / Treatment
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* Drug: Intranasal Drug
* Drug: Oral Tablet
* Other: Intranasal Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Nasal spray solution without active ingredient | Other: Intranasal Placebo<br>* Intranasal administration of solution without betahistine dihydrochloride; Dosing 3 times a day<br>|
| Experimental: 1 mg AM-125<br>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<br>* Intranasal administration of solution with betahistine dihydrochloride; Dosing 3 times a day<br>|
| Experimental: 10 mg AM-125<br>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<br>* Intranasal administration of solution with betahistine dihydrochloride; Dosing 3 times a day<br>|
| Experimental: 20 mg AM-125<br>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<br>* Intranasal administration of solution with betahistine dihydrochloride; Dosing 3 times a day<br>|
| Experimental: Oral 16 mg betahistine<br>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<br>* Oral dosing with tablets 3 times a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of time standing on foam (eyes closed) |  | Day 3 to Day 14 | 
| 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. | Day 3 to Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vertigo, Balance