EU Clinical Trial 2018-002474-52

Multicenter randomized controlled phase 2 trial to evaluate AM-125 in the treatment of acute peripheral vertigo following vestibular schwannoma resection (TRAVERS)  Jun 3, 2019

Main objective of the trial: The primary objective of Part A is a. to explore and provide an estimate of the dose response curve for AM-125, and b. to evaluate the efficacy of AM-125 compared to placebo in reducing the symptoms of vestibular dysfunction and accelerating vestibular compensation following vestibular schwannoma resection. The primary objective of Part B is to evaluate the efficacy of two selected doses of AM-125 versus placebo, as determined based on the results from Part A, in reducing the symptoms of vestibular dysfunction and accelerating vestibular compensation following vestibular schwannoma resection compared to placebo.

Parties

Sponsors
Countries
BE CA CZ DE FR GB NL PL
Keywords
AM-125 Betahistine dihydrochloride Vestibular vertigo betahistine dihydrochloride betaserc

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Source:  EMA Last updated:  Jun 5, 2019

From ClinicalTrialsRegister.eu, a database of the European Medicines Agency. This record may not reflect the most current and accurate data available from the EMA.