Vestibular schwannomas with indication for surgery MedDRA version: 20.0 Level: LLT Classification code 10048925 Term: Acoustic schwannoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Nimotop® S, 10mg/50ml, Solution for infusion
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: NIMODIPINE
CAS Number: 66085-59-4
Concentration unit: mg/ml milligram(s)/millil
Sponsors
Martin-Luther-Universität Halle-Wittenberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Vestibular schwannomas (Koos I-IV) with indication for surgery - Age: 18 years and older - Preoperative pure tone audiometry (not older than 3 months prior to surgery), hearing function according to Gardner-Robertson scale (GR) 1-3 - Preoperative MRI (not older than 6 months prior to surgery) - Written informed consent - Safe contraception measures for males and females. Procedures with a pearl index of less than 1% or abstinence apply as safe pregnancy prevention measures - Ability to understand and give informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 286 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: - Hearing function GR 4-5. - conductive hearing loss at affected side - Previously irradiated or surgical treated VS. - Neurofibromatosis, other brain tumors, other reasons for inoperability - Pregnancy and lactation period - Known hypersensitivity to nimodipine or any of the excipients (ethanol, Macrogol, sodiumcitrate, citric acid) to be used for nimodipine infusion - Historx of (reformed alcoholic) or persistent abuse of alcohol - Known current kidney or liver insufficiency - Any medical condition that in the opinion of the investigator would not permit participation in the clinical trial. - Unstable angina pectoris and/or Myocardial infarction during the last four weeks before start of treatment - Subjects with psychological, psychiatric, neurological, familial, sociological, or geographical conditions that do not permit compliance with the protocol - Participation in another interventional trial simultaneously and within the last 30 days prior to inclusion (registries or observational studies allowed) sever, uncontrolled, symptomatic hypotension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy and safety of prophylactic nimodipine treatment on hearing preservation after VS surgery in comparison to standard care only;Secondary Objective: Secondary aims are to compare the postoperative and late postoperative cochlear nerve function according to GR scale with preoperative function, change in PTA and WRSmax, compare GR-scores and AAOHNS-scores, intraoperative BAEP mean values, to investigate subjective quality of life, the anatomical preservation of the cochlear nerve and wave V and safety.;Primary end point(s): Postoperative cochlear nerve function measured before discharge according to GR scale 1-3 versus GR 4-5 (binary);Timepoint(s) of evaluation of this end point: after surgery before hospital discharge | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Postoperative deterioration of cochlear nerve function of at least one grade according to the GR scale compared with its preoperative function - change in PTA and WRSmax - GR-scores and AAOHNS-scores - intraoperative deterioration of BAEP mean values (amplitudes and latencies) - anatomical preservation of cochlear nerve and preservation of wave V - patient-reported outcome scores: quality of life and communication competence (SF-12, HHIE, PANQOL) - safety ;Timepoint(s) of evaluation of this end point: – after surgery and before hospital discharge (GR1-3 vs GR4-5; comparision GR preoperatively vs postoperatively) - 3 to 6 months after surgery (comparision GR preoperatively vs postoperatively; quality of life) - intraoperatively (BAEPs) | — |
Countries
Germany
Contacts
Public Contactcoordinating investigator
Universitätsklinikum Halle
Outcome results
None listed