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Efficacy and Safety of Intranasal Betahistine in the Treatment of Surgery-Induced Acute Vestibular Syndrome: A Double-Blind, Randomized, Placebo-Controlled Phase 2 Study.
Van de Heyning, Paul; Betka, Jan; Chovanec, Martin; Devèze, Arnaud; Giannuzzi, Anna Lisa; Krempaská, Silvia; Przewozny, Tomasz; Scheich, Matthias; Strupp, Michael; Van Rompaey, Vincent; Meyer, Thomas.
Afiliação
  • Van de Heyning P; Department of Otorhinolaryngology, Antwerp University Hospital, Faculty of Medicine and Health Sciences, University of Antwerp, Belgium.
  • Betka J; Department of Otorhinolaryngology and Head and Neck Surgery, Charles University, 1st Medical Faculty, University Hospital Motol, Prague, Czech Republic.
  • Chovanec M; Department of Otorhinolaryngology, Charles University, 3rd Medical Faculty, University Hospital Královské Vinohrady, Prague, Czech Republic.
  • Devèze A; Ear and Skull Base Institute, Clairval Hospital, Ramsay Health Care, Marseille, France.
  • Giannuzzi AL; Gruppo Otologico, Piacenza, Italy.
  • Krempaská S; Department of Otorhinolaryngology, Pavol Jozef Safárik University, Kosice, Slovakia.
  • Przewozny T; Department of Otolaryngology, Medical University of Gdansk, Gdansk, Poland.
  • Scheich M; Department of Oto-Rhino-Laryngology, Plastic, Aesthetic and Reconstructive Head and Neck Surgery, University Hospital, Würzburg, Germany.
  • Strupp M; Department of Neurology and German Center for Vertigo and Balance Disorders, Ludwig Maximilians University Hospital, Munich, Germany.
  • Van Rompaey V; Department of Otorhinolaryngology, Antwerp University Hospital, Faculty of Medicine and Health Sciences, University of Antwerp, Belgium.
  • Meyer T; Auris Medical AG, Basel, Switzerland.
Otol Neurotol ; 44(5): 493-501, 2023 06 01.
Article em En | MEDLINE | ID: mdl-37026797
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 16 mg p.o. t.i.d. for 4 weeks, starting 3 days postsurgery; standardized vestibular rehabilitation. MAIN OUTCOME

MEASURES:

Tandem Romberg test (TRT) for primary efficacy, standing on foam, tandem gait, subjective visual vertical and spontaneous nystagmus for secondary efficacy, Vestibular Rehabilitation Benefit Questionnaire (VRBQ) for exploratory efficacy; nasal symptoms and adverse events for safety.

RESULTS:

At treatment period end, mean TRT improvement was 10.9 seconds for the 20-mg group versus 7.4 seconds for the placebo group (mixed model repeated measures, 90% confidence interval = 0.2 to 6.7 s; p = 0.08). This was corroborated by nominally higher frequency of complete spontaneous nystagmus resolution (34.5% vs. 20.0% of patients) and improvement in the VRBQ; the other secondary endpoints showed no treatment effect. The study drug was well tolerated and safe.

CONCLUSIONS:

Intranasal betahistine may help accelerate vestibular compensation and alleviate signs and symptoms of vestibular dysfunction in surgery-induced AVS. Further evaluation in a confirmatory manner appears warranted.
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Beta-Histina / Nistagmo Patológico Tipo de estudo: Clinical_trials / Observational_studies Limite: Adolescent / Adult / Aged / Humans / Middle aged Idioma: En Ano de publicação: 2023 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Beta-Histina / Nistagmo Patológico Tipo de estudo: Clinical_trials / Observational_studies Limite: Adolescent / Adult / Aged / Humans / Middle aged Idioma: En Ano de publicação: 2023 Tipo de documento: Article