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    Summary
    EudraCT Number:2019-002317-19
    Sponsor's Protocol Code Number:KKSH155
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-01-23
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2019-002317-19
    A.3Full title of the trial
    Prophylactic nimodipine treatment for hearing preservation after vestibular schwannoma surgery: a randomized multi-center phase III trial
    Prophylaktische Nimodipin-Therapie zum Erhalt der Hörfunktion bei der Resektion von Akustikusneurinomen : eine randomisierte, multi-zentrische Phase III Studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate the efficacy of prophylactic nimodipine treatment on hearing preservation after vestibularis schwannoma surgery
    Studie zur Untersuchung der Wirksamkeit der vorherigen Nimodipin-Gabe auf das Hörvermögen nach Operation eines Vestibulaisschwannoms
    A.3.2Name or abbreviated title of the trial where available
    AkNiPro2
    AkNiPro2
    A.4.1Sponsor's protocol code numberKKSH155
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMartin-Luther-Universität Halle-Wittenberg
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportdeutsche Forschungsgemeinschaft
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum Halle
    B.5.2Functional name of contact pointcoordinating investigator
    B.5.3 Address:
    B.5.3.1Street AddressErnst-Grube-Strasse 40
    B.5.3.2Town/ cityHalle (Saale)
    B.5.3.3Post code06120
    B.5.3.4CountryGermany
    B.5.4Telephone number+49345557 1399
    B.5.5Fax number+49345 557 1141
    B.5.6E-mailchristian.scheller@uk-halle.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Nimotop® S, 10mg/50ml, Solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Vital GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNIMODIPINE
    D.3.9.1CAS number 66085-59-4
    D.3.9.4EV Substance CodeSUB09297MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Vestibular schwannomas with indication for surgery
    Vestibularisschwannom mit Indikation zur Operation
    E.1.1.1Medical condition in easily understood language
    Vestibular schwannomas with indication for surgery
    Vestibularisschwannom mit Indikation zur Operation
    E.1.1.2Therapeutic 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.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10048925
    E.1.2Term Acoustic schwannoma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.
    E.2.2Secondary 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.
    E.2.3Trial contains a sub-study No
    E.3Principal 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
    E.4Principal 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
    E.5 End points
    E.5.1Primary 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)
    E.5.1.1Timepoint(s) of evaluation of this end point
    after surgery before hospital discharge
    nach OP vor Krankenhausentlassung
    E.5.2Secondary 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
    - 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
    E.5.2.1Timepoint(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)
    – 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)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    OP als Standardtherapie
    surgery only as standard of care
    E.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial 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
    closed data base after LVLS
    geschlossene Datenbank nach letzter Studienvisite des letzten Patienten
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 286
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state336
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After end of the trial, the postoperative treatment and therapy of the VS will be performed according to the German treatment guidelines / clinical routine and is left to the investigator’s discretion
    Nach dem Ende der Studie erfolgt die postoperative Behandlung der VS-Patienten entsprechend der deutschen Leitlinien für Ärzte sowie der klinischen Routine und ist Entscheidung der Prüfärzte.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-02-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-17
    P. End of Trial
    P.End of Trial StatusOngoing
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