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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
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
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Not yet recruiting NCT03974867 - Vestibular Prognosis Assessment of ISSNHL With Vestibular Dysfunction Treated With Oral or Intratympanic Glucocorticoids N/A
Recruiting NCT05192564 - Exercise and Vestibular Hypofunction N/A