drugset / Trial / NCT03908567
AM-125 in the Treatment of Acute Peripheral Vertigo Following Neurosurgery
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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.
Timeline
- Start
- 2019-07-18
- Primary completion
- 2022-03-28
- Completion
- 2022-03-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Betahistine | Small molecule | 1 mg | Intranasal |
| Subject | Betahistine | Small molecule | 10 mg | Intranasal |
| Subject | Betahistine | Small molecule | 16 mg | Intranasal |
| Subject | Betahistine | Small molecule | 20 mg | Intranasal |