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

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ClinicalTrials.gov Identifier: NCT03908567
Recruitment Status : Recruiting
First Posted : April 9, 2019
Last Update Posted : September 22, 2021
Sponsor:
Information provided by (Responsible Party):
Auris Medical, Inc. ( Auris Medical AG )

Tracking Information
First Submitted Date  ICMJE April 5, 2019
First Posted Date  ICMJE April 9, 2019
Last Update Posted Date September 22, 2021
Actual Study Start Date  ICMJE July 18, 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2019)
  • Improvement of time standing on foam (eyes closed) [ Time Frame: Day 3 to Day 14 ]
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AM-125 in the Treatment of Acute Peripheral Vertigo Following Neurosurgery
Official Title  ICMJE Multicenter Randomized Controlled Phase 2 Trial to Evaluate AM-125 in the Treatment of Acute Peripheral Vertigo Following Neurosurgery (TRAVERS)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Vestibular Vertigo
Intervention  ICMJE
  • Drug: Intranasal Drug
    Intranasal administration of solution with betahistine dihydrochloride; Dosing 3 times a day
  • Drug: 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
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Nasal spray solution without active ingredient
    Intervention: Other: Intranasal Placebo
  • 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.
    Intervention: Drug: Intranasal Drug
  • 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.
    Intervention: Drug: Intranasal Drug
  • 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.
    Intervention: Drug: Intranasal Drug
  • 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.
    Intervention: Drug: Oral Tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 28, 2020)
118
Original Estimated Enrollment  ICMJE
 (submitted: April 8, 2019)
138
Estimated Study Completion Date  ICMJE January 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Auris Medical 0041 61 201 1350 hear@aurismedical.com
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03908567
Other Study ID Numbers  ICMJE AM-125-CL-18-01
2018-002474-52 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Auris Medical, Inc. ( Auris Medical AG )
Study Sponsor  ICMJE Auris Medical AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Auris Medical, Inc.
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP