Treatment of vertigo after removal of a tumor of the balance and hearing nerve after neurosurgery, which damages or cuts the vestibular nerve (balance). This trial explores the efficacy and safety of AM-125 in the treatment of acute vertigo. In this proof of concept trial patients experiencing vertigo after neurosurgery (vestibular schwannoma labyrinthectomy and vestibular neurectomy) will receive AM-125 or placebo. It evaluates the potential of AM-125 versus placebo in reducing the symptoms of vestibular dysfunction and accelerating vestibular compensation following neurosurgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
124
Intranasal administration of solution with betahistine dihydrochloride; Dosing 3 times a day
Oral dosing with tablets 3 times a day
Intranasal administration of solution without betahistine dihydrochloride; Dosing 3 times a day
CHP Clairval
Marseille, France
Improvement of time standing on foam (eyes closed)
Time frame: Day 3 to Day 14
Improvement in tandem Romberg test (eyes closed)
Participants will be asked to stand straight in tandem stand (heel of one foot touching the toes of the other foot) and duration in this position will be measured.
Time frame: Day 3 to Day 14
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