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

Vestibular Vertigo Clinical Trial

— TRAVERS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03908567
• Other study ID #: AM-125-CL-18-01
• Secondary ID: 2018-002474-52
• Status: Completed
• Phase: Phase 2
• Start date: July 18, 2019
• Est. completion date: March 28, 2022

Study information

• Verified date: September 2023
• Source: Auris Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: March 28, 2022
• Est. primary completion date: March 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dizziness
• Vertigo
• Vestibular Vertigo

Intervention

Drug:
• Intranasal Drug
Intranasal administration of solution with betahistine dihydrochloride; Dosing 3 times a day
• Oral Tablet
Oral dosing with tablets 3 times a day

Other:
• Intranasal Placebo
Intranasal administration of solution without betahistine dihydrochloride; Dosing 3 times a day

Locations

Country	Name	City	State
France	CHP Clairval	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Auris Medical AG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of time standing on foam (eyes closed)		Day 3 to Day 14
Primary	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

External Links

•   Link to peer-reviewed publication of study
•   Link to Result entry in clinicaltrialsregister.eu