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AM-125 in the Treatment of Acute Peripheral Vertigo Following Vestibular Schwannoma Resection (TRAVERS)

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ClinicalTrials.gov Identifier: NCT03908567
Recruitment Status : Not yet recruiting
First Posted : April 9, 2019
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
Auris Medical, Inc. ( Auris Medical AG )

Brief Summary:

Treatment of vertigo after removal of a tumor of the balance and hearing nerve.

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 vestibular schwannoma resection 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 vestibular schwannoma resection.


Condition or disease Intervention/treatment Phase
Vestibular Vertigo Drug: Intranasal Drug Drug: Oral Tablet Other: Intranasal Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: For intranasal subjects, allocation is blinded. The oral arm is an open-label arm.
Primary Purpose: Treatment
Official Title: Multicenter Randomized Controlled Phase 2 Trial to Evaluate AM-125 in the Treatment of Acute Peripheral Vertigo Following Vestibular Schwannoma Resection (TRAVERS)
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : May 2020


Arm Intervention/treatment
Placebo Comparator: Placebo
Nasal spray solution without active ingredient
Other: Intranasal Placebo
Intranasal administration of solution without betahistine dihydrochloride; Dosing 3 times a day

Experimental: 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.
Drug: Intranasal Drug
Intranasal administration of solution with betahistine dihydrochloride; Dosing 3 times a day

Experimental: 2.5 mg AM-125
Nasal spray solution with 12.5 mg/mL betahistine dihydrochloride. Administered three times daily as 1 spray per nostril. Total daily dose is 7.5 mg betahistine dihydrochloride.
Drug: Intranasal Drug
Intranasal administration of solution with betahistine dihydrochloride; Dosing 3 times a day

Experimental: 5 mg AM-125
Nasal spray solution with 25 mg/mL betahistine dihydrochloride. Administered three times daily as 1 spray per nostril. Total daily dose is 15 mg betahistine dihydrochloride.
Drug: Intranasal Drug
Intranasal administration of solution with betahistine dihydrochloride; Dosing 3 times a day

Experimental: 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.
Drug: Intranasal Drug
Intranasal administration of solution with betahistine dihydrochloride; Dosing 3 times a day

Experimental: 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.
Drug: Intranasal Drug
Intranasal administration of solution with betahistine dihydrochloride; Dosing 3 times a day

Experimental: 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.
Drug: Oral Tablet
Oral dosing with tablets 3 times a day




Primary Outcome Measures :
  1. Improvement of time standing on foam (eyes closed) [ Time Frame: Day 3 to Day 14 ]
  2. Improvement in tandem Romberg test (eyes closed) [ Time Frame: Day 3 to Day 14 ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  1. Scheduled for vestibular schwannoma resection.
  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 compress the brainstem, documented by magnetic resonance imaging not older than six months.
  3. Confirmed vestibular function on both sides

Main Exclusion Criteria:

  1. Prior radiotherapy (e.g. gammaknife) affecting the brain-stem.
  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 gentamicin therapy within the past three months prior to VS surgery.
  4. Any clinically relevant nasal obstruction or pathology precluding effective and/or safe intranasal delivery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03908567


Contacts
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Contact: Auris Medical 0041 61 201 1350 hear@aurismedical.com

Sponsors and Collaborators
Auris Medical AG

Additional Information:
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Responsible Party: Auris Medical AG
ClinicalTrials.gov Identifier: NCT03908567     History of Changes
Other Study ID Numbers: AM-125-CL-18-01
2018-002474-52 ( EudraCT Number )
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Auris Medical, Inc. ( Auris Medical AG ):
Vertigo
Balance
Additional relevant MeSH terms:
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Neurilemmoma
Neuroma, Acoustic
Vertigo
Dizziness
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensation Disorders
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neuroma
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Cranial Nerve Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Peripheral Nervous System Neoplasms
Vestibulocochlear Nerve Diseases
Retrocochlear Diseases
Otorhinolaryngologic Neoplasms
Cranial Nerve Diseases
Betahistine
Pharmaceutical Solutions