Efficacy and Safety of Intranasal Betahistine in the Treatment of Surgery-Induced Acute Vestibular Syndrome: A Double-Blind, Randomized, Placebo-Controlled Phase 2 Study.
Otol Neurotol
; 44(5): 493-501, 2023 06 01.
Article
in 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). STUDYDESIGN:
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 OUTCOMEMEASURES:
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.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Betahistine
/
Nystagmus, Pathologic
Type of study:
Clinical_trials
/
Observational_studies
Limits:
Adolescent
/
Adult
/
Aged
/
Humans
/
Middle aged
Language:
En
Journal:
Otol Neurotol
Journal subject:
NEUROLOGIA
/
OTORRINOLARINGOLOGIA
Year:
2023
Document type:
Article
Affiliation country:
Bélgica