E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Vestibular schwannomas with indication for surgery |
Vestibularisschwannom mit Indikation zur Operation |
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E.1.1.1 | Medical condition in easily understood language |
Vestibular schwannomas with indication for surgery |
Vestibularisschwannom mit Indikation zur Operation |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10048925 |
E.1.2 | Term | Acoustic schwannoma |
E.1.2 | System Organ Class | 100000004864 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the efficacy and safety of prophylactic nimodipine treatment on hearing preservation after VS surgery in comparison to standard care only |
Ziel der Studie ist es, den Effekt und die Sicherheit der prophylactischen Nimodipingabe auf die Hörfunktion nach VS Operation im Vergleich zur Standard-Therapie zu untersuchen. |
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E.2.2 | Secondary objectives of the trial |
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. |
Sekundäre Ziele sind der Vergleich der Veränderung der postoperativen und späten postoperativen Funktion des Nervus Cochlearis anhand der GR-Skala zur preoperativen Funktion, Änderung in PTA und WRSmax, Vergleich der GR-Scores mit AAOHNS-Scores, intraoperative BAEP-Werte. Weiterhin soll die Lebensqualität, der anatomische Erhalt des nervus cochlearis und der Wave V sowie die Sicherheit untersucht werden. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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% apply as safe pregnancy prevention measures Ability to understand and give informed consent |
– Vestibularisschwannom (Koos I-IV) mit Indikation zur Operation - Alter: über 18 Jahre - preoperatives Audiogramm (nicht älter als 3 Monate), Hörfunktion nach Gardner-Robertson Skala (GR) 1-3 - preoperatives MRT (nicht älter als 6 Monate) - schriftliche, informierte Einwilligung - Effektive Kontrazeption für Frauen und Männer (Pearl Index <1). Einwilligungsfähigkeit |
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E.4 | Principal 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 |
– Hörfunktion GR 4-5 - Hörverlust anhand der Knochenleitung auf der betroffenen Seite, falls messbar - vorangegangene radiologische oder chriurgische Behandlung des VS - Neurofibromatose, andere Hirntumore, andere Gründe die gegen eine OP sprechen - Schwangerschaft oder Stillzeit - bekannte Allergien gegen Nimodipin oder Bestandteile für die Infusion - trockene Alkoholiker oder bestehender Alkoholmissbrauch - bekannte aktuelle Nieren- oder Leberinsuffizienz - jegliches medizinisches Ereignis, das nach Ermessen des Prüfarztes gegen einen Einschluss spricht - instabile Angina Pectoris oder Myokardinfarkt innerhalb der letzten 4 Wochen vor Behandlungsstart - psychische, psychologische, neurologische, familiäre, soziale oder geografische Gegebenheiten, die gegen eine Compliance sprechen - Gleichzeitige oder innerhalb von 30 Tagen liegende Teilnahme an einer anderen klinischen Prüfung mit Arzneimitteln; schwere, unkontrollierte, symptomatische Hypotonie
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E.5 End points |
E.5.1 | Primary end point(s) |
Postoperative cochlear nerve function measured before discharge according to GR scale 1-3 versus GR 4-5 (binary) |
Vor Krankenhausentlassung postoperative Messung der Funktion des Nervus Cochlearis nach GR 1-3 versus GR 4-5 (binär) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
after surgery before hospital discharge |
nach OP vor Krankenhausentlassung |
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E.5.2 | 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
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- späte postoperative Messung der Funktion des Nervus Cochlearis nach GR 1-3 versus GR 4-5 (binär). - Vergleich der Verschlechterung der postoperativen (früh und spät) Funktion des Nervus Cochlearis anhand der GR-Skala zur preoperativen Funktion - Veränderung der Hörschwelle und des Sprachverständnisses - Vergleich der GR-Beurteilung mit der AAOHANS-Beurteilung - intraoperative Verschlechterung der BAEP Mittelwerte - Lebensqualität und Kommunikationsfähigkeit anhand von Fragebögen - Erhalt des Nervus cochlearis und der Wave V (BAEP) - Sicherheit |
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E.5.2.1 | 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)
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– nach OP und vor Krankenhausentlassung (GR1-3 vs GR4-5; Vergleich GR preoperativ vs postoperativ) - 3 bis 6 Monate nach OP (Vergleich GR preoperativ vs postoperativ; Lebensqualität) - intraoperativ (BAEPs) - Vergleich zwischen beiden postoperativen Ergebnissen (PTA und WRSmax)
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
OP als Standardtherapie |
surgery only as standard of care |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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closed data base after LVLS |
geschlossene Datenbank nach letzter Studienvisite des letzten Patienten |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |