SYF565ee96502bc4012bd369ee7ad295beeRegistry ID: 2024-518182-10-00|UnknownPhase 3Results
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interventional
N/A
1 country
8
To assess the efficacy and safety of prophylactic nimodipine treatment on hearing preservation after VS surgery in comparison to standard care only.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 11, 2024
Actual (reported)Postoperative cochlear nerve function measured before discharge according to GR scale 1-3 versus GR 4-5 (binary)
Late postoperative cochlear nerve function measured at follow up three to six months after surgery (end of study) according to GR scale 1-3 versus GR 4-5 (binary)
Postoperative deterioration of cochlear nerve function of at least one grade according to the GR scale compared with its preoperative function (binary)
Late postoperative deterioration of cochlear nerve function of at least one grade according to the GR scale compared with its preoperative function measured at follow up three to six months after surgery (end of study) (binary)
Change of pure-tone thresholds (PTA) and speech discrimination score (WRSmax)
Comparison between GR-scores and AAOHNS-scores
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Nimotop® S, 10 mg/50 ml, Infusionslösung
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Nimotop® S, 10 mg/50 ml, Infusionslösung
Named ingredient: Nimodipine
View registry recordMedical Center - University Of Freiburg
Freiburg Im Breisgau, 79106, Germany
Universitaetsklinikum Tuebingen AöR
Tuebingen, 72076, Germany
Charite Universitaetsmedizin Berlin KöR
Berlin, 10117, Germany
Prof. Christian Scheller
First Submitted
October 11, 2024
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved:
Super-Selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Vestibular Schwannoma
Contact the study team to confirm eligibility.
Universitaetsklinikum Muenster AöR
Muenster, 48149, Germany
HELIOS Klinikum Erfurt GmbH
Erfurt, 99089, Germany
Universitaetsmedizin Goettingen
Goettingen, 37075, Germany
Universitaetsklinikum Wuerzburg AöR
Wuerzburg, 97080, Germany
Martin-Luther-Universitaet Halle-Wittenberg
Halle (Saale), 06120, Germany