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

NCT03908567 | Completed Phase 2 DMC

• 2 other identifiers: AM-125-CL-18-012018-002474-52
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vestibular Vertigo

Keywords

Vertigo; Balance

Outcome Measures

Primary Outcomes (2)

• Improvement of time standing on foam (eyes closed)

  Day 3 to Day 14

• 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

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Nasal spray solution without active ingredient

Other: Intranasal Placebo

1 mg AM-125

EXPERIMENTAL

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.

Drug: Intranasal Drug

10 mg AM-125

EXPERIMENTAL

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.

Drug: Intranasal Drug

20 mg AM-125

EXPERIMENTAL

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.

Drug: Intranasal Drug

Oral 16 mg betahistine

EXPERIMENTAL

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

Drug: Oral Tablet

Interventions

Intranasal Drug DRUG

Intranasal administration of solution with betahistine dihydrochloride; Dosing 3 times a day

1 mg AM-125; 10 mg AM-125; 20 mg AM-125

Oral Tablet DRUG

Oral dosing with tablets 3 times a day

Oral 16 mg betahistine

Intranasal Placebo OTHER

Intranasal administration of solution without betahistine dihydrochloride; Dosing 3 times a day

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled for neurosurgery (vestibular schwannoma resection, labyrinthectomy or vestibular neurectomy).
• 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.
• Confirmed vestibular function on both sides.

You may not qualify if:

• Prior radiotherapy (gammaknife, intensity modulated radiation therapy) irradiating the brain-stem with more than 4 Gy.
• 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).
• Vestibular rehabilitation therapy or presurgical gentamicin therapy (i.e. "pre-habilitation therapy") within the past three months prior neurosurgery.
• Any clinically relevant nasal obstruction or pathology precluding effective and/or safe intranasal delivery.

Sponsors & Collaborators

• Auris Medical AG: lead

Study Sites (1)

CHP Clairval

Marseille, France

Location

Related Links

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

MeSH Terms

Conditions

Vertigo

Interventions

Administration, Intranasal; Tablets

Condition Hierarchy (Ancestors)

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Administration, Mucosal; Administration, Topical; Drug Administration Routes; Drug Therapy; Therapeutics; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: For intranasal subjects, allocation is blinded. The oral arm is an open-label arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 9, 2019
• Study Start: July 18, 2019
• Primary Completion: March 28, 2022
• Study Completion: March 28, 2022
• Last Updated: September 14, 2023

Record last verified: 2023-09

Locations

FR (1)