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

Auris Medical

Status and phase: Completed; Phase 2

Conditions: Vestibular Vertigo

Treatments: Other: Intranasal Placebo; Drug: Oral Tablet; Drug: Intranasal Drug

Study type: Interventional

Funder types: Industry

Identifiers

NCT03908567

2018-002474-52 (EudraCT Number)

AM-125-CL-18-01

Details and patient eligibility

About

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.

Enrollment: 124 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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124 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Nasal spray solution without active ingredient

Treatment:

Other: Intranasal Placebo

1 mg AM-125

Experimental group

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.

Treatment:

Drug: Intranasal Drug

10 mg AM-125

Experimental group

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.

Treatment:

Drug: Intranasal Drug

20 mg AM-125

Experimental group

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.

Treatment:

Drug: Intranasal Drug

Oral 16 mg betahistine

Experimental group

Description:

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

Treatment:

Drug: Oral Tablet