Studieninformationen
Kurztitel:
AM-125-CL-18-01 (TRAVERS)
Beschreibung:
Multicenter Randomized Controlled Phase 2 Trial to Evaluate AM-125 in the Treatment of Acute Peripheral Vertigo Following Neurosurgery (TRAVERS)
Studiendesign:
Phase II, , Peer Reviewed, Multizentrisch, International
Therapielinien:
Alter:
18 Jahre - 70 Jahre
Ein-/Ausschlusskriterien:
Main 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. Main 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.
NCT-Nummer:
Eudract-Nummer:
Studienaktive Standorte
common:study_status_active
Universitätsklinikum Würzburg
97080 Würzburg
Klinik und Poliklinik für Hals-, Nasen- und Ohrenkrankheiten, plastische und ästhetische Operationen
Herr PD Dr. Matthias Scheich
Scheich_M@ukw.de