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

NCT03908567 — Phase 2, Completed, 124 participants, Auris Medical AG

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

Registry	NCT03908567, acronym TRAVERS
Status	Completed
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	124 (Actual)
Sponsor	Auris Medical AG (Industry)
Conditions	Vestibular Vertigo
Interventions	Intranasal Drug, Oral Tablet, Intranasal Placebo (Drug, other)
Dates	start 2019-07-18, primary completion 2022-03-28, completion 2022-03-28, first posted 2019-04-09, last updated 2023-09-14
Locations	1 site in France

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Placebo	Placebo comparator	Other: Intranasal Placebo	Nasal spray solution without active ingredient
1 mg AM-125	Experimental	Drug: Intranasal Drug	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.
10 mg AM-125	Experimental	Drug: Intranasal Drug	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.
20 mg AM-125	Experimental	Drug: Intranasal Drug	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.
Oral 16 mg betahistine	Experimental	Drug: Oral Tablet	Tablets containing betahistine dihydrochloride. Administered three times daily as 1 tablet per time. Total daily dose is 48 mg oral betahistine dihydrochloride.

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

+Outcome measures

Primary outcomes

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.

+Eligibility

Sex: All, ages: 18 Years to 70 Years

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.

+Locations (1)

Facility	City	Country	Status
CHP Clairval	Marseille	France

+Funding

NIH grants: 2018