CompletedPhase 2

AM-125 in the Treatment of Acute Peripheral Vertigo Following Neurosurgery

France124 participantsStarted 2019-07-18

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Scheduled for neurosurgery (vestibular schwannoma resection, labyrinthectomy or vestibular neurectomy).
✓. Small to moderately large vestibular schwannoma (Koos grade I-III; Samii grade T1-T3b; ≤ 30 mm in diameter in cerebellopontine angle) that does not displace the brainstem, documented by magnetic resonance imaging not older than six months or Indication for labyrinthectomy or vestibular neurectomy.
✓. Confirmed vestibular function on both sides.

Exclusion criteria

✕. Prior radiotherapy (gammaknife, intensity modulated radiation therapy) irradiating the brain-stem with more than 4 Gy.
✕. Any ongoing other peripheral vestibular disorder (e.g. Meniere's disease, benign paroxysmal vertigo, vestibular neuritis) or central vestibular disorder (e.g. vestibular migraine, central vertigo).
✕. Vestibular rehabilitation therapy or presurgical gentamicin therapy (i.e. "pre-habilitation therapy") within the past three months prior neurosurgery.
✕. Any clinically relevant nasal obstruction or pathology precluding effective and/or safe intranasal delivery.

What they're measuring

Improvement of time standing on foam (eyes closed)

Timeframe: Day 3 to Day 14

Improvement in tandem Romberg test (eyes closed)

Timeframe: Day 3 to Day 14

Trial details

NCT IDNCT03908567

SponsorAuris Medical AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-03-28

View on ClinicalTrials.gov More Vestibular Vertigo trials