Efficacy and Safety of Intranasal Betahistine in the Treatment of Surgery-Induced Acute Vestibular Syndrome: A Double-Blind, Randomized, Placebo-Controlled Phase 2 Study.

ABSTRACT:

Objective

To evaluate the safety and efficacy of AM-125 nasal spray (intranasal betahistine) in the treatment of surgery-induced acute vestibular syndrome (AVS).

Study design

Prospective, double-blind, randomized, placebo-controlled exploratory phase 2 study with dose escalation (part A) followed by parallel dose testing (part B); open-label oral treatment for reference.

Setting

Twelve European study sites (tertiary referral centers).

Patients

One hundred and twenty-four patients 18 to 70 years old undergoing surgery for vestibular schwannoma resection, labyrinthectomy or vestibular neurectomy with confirmed bilateral vestibular function presurgery and acute peripheral vertigo postsurgery.

Interventions

AM-125 (1, 10, or 20 mg) or placebo or betahistine

SUBMITTER: Van de Heyning P 

PROVIDER: S-EPMC10184813 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature