AM-125 in the treatment of acute peripheral vertigo (TRAVERS)
Research type
Research Study
Full title
Multicentre randomized controlled phase 2 trial to evaluate AM-125 in the treatment of acute peripheral vertigo following vestibular schwannoma resection (TRAVERS)
IRAS ID
264912
Contact name
Patrick Axon
Contact email
Sponsor organisation
Auris Medical AG
Eudract number
2018-002474-52
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 31 days
Research summary
Research Summary
This is a study investigating the effectiveness and safety of intranasal betahistine in patients suffering from vertigo (giddiness) after the removal of a vestibular schwannoma - a slow-growing tumour that grows from cells around the nerve linking the inner ear with the brain. This surgery is not part of the study.
The study is split into two parts:
Part A contains 5 groups of 10 patients, each group will receive different dose of betahistine dihydrochloride (AM-125) or placebo, delivered by nasal spray and the 6th group will receive the reference drug (a tablet taken by mouth, also containing betahistine dihydrochloride).
Medical experts will assess the safest and best performing doses to choose two safe and effective doses of AM-125, which will be tested more in Part B.
In Part B, the patients will be randomised into one of three groups; a high dose of AM-125, a low dose of AM-125 or placebo - all delivered by nasal spray.
Each group will take their medication for 4 weeks and be followed up for a further 2 weeks.Summary of results
Results suggest that intranasal betahistine AM-125, is effective as well as safe and well-tolerated.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
19/EE/0215
Date of REC Opinion
4 Oct 2019
REC opinion
Further Information Favourable Opinion