AM-125 in the Treatment of Acute Peripheral Vertigo Following Neurosurgery
NCT ID: NCT03908567
Last Updated: 2023-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
124 participants
INTERVENTIONAL
2019-07-18
2022-03-28
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Nasal spray solution without active ingredient
Intranasal Placebo
Intranasal administration of solution without betahistine dihydrochloride; Dosing 3 times a day
1 mg AM-125
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.
Intranasal Drug
Intranasal administration of solution with betahistine dihydrochloride; Dosing 3 times a day
10 mg AM-125
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.
Intranasal Drug
Intranasal administration of solution with betahistine dihydrochloride; Dosing 3 times a day
20 mg AM-125
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.
Intranasal Drug
Intranasal administration of solution with betahistine dihydrochloride; Dosing 3 times a day
Oral 16 mg betahistine
Tablets containing betahistine dihydrochloride. Administered three times daily as 1 tablet per time. Total daily dose is 48 mg oral betahistine dihydrochloride.
Oral Tablet
Oral dosing with tablets 3 times a day
Interventions
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Intranasal Drug
Intranasal administration of solution with betahistine dihydrochloride; Dosing 3 times a day
Oral Tablet
Oral dosing with tablets 3 times a day
Intranasal Placebo
Intranasal administration of solution without betahistine dihydrochloride; Dosing 3 times a day
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
70 Years
ALL
No
Sponsors
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Auris Medical AG
INDUSTRY
Responsible Party
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Locations
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CHP Clairval
Marseille, , France
Countries
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Related Links
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Link to Result entry in clinicaltrialsregister.eu
Link to peer-reviewed publication of study
Other Identifiers
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2018-002474-52
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AM-125-CL-18-01
Identifier Type: -
Identifier Source: org_study_id
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