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    Summary
    EudraCT Number:2017-002616-13
    Sponsor's Protocol Code Number:Unknown
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-12-14
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2017-002616-13
    A.3Full title of the trial
    The effect of perioperative intravenous s-ketamine on acute and chronic postoperative craniotomy pain compared to placebo
    Het effect van perioperatieve intraveneuze s-ketamine op acute en chronische postoperatieve craniotomie pijn vergeleken met een placebo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    S-ketamine for acute and chronic headache after brainsurgery
    S-ketamine voor acute en chronische hoofdpijn na een hersenoperatie
    A.3.2Name or abbreviated title of the trial where available
    ESPAIN
    A.4.1Sponsor's protocol code numberUnknown
    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 SponsorMaastricht Universitair Medisch Centrum
    B.1.3.4CountryNetherlands
    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 supportMaastricht UMC+
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMaastricht UMC+
    B.5.2Functional name of contact pointSecretariat Neurosurgery
    B.5.3 Address:
    B.5.3.1Street AddressP. debyelaan 25
    B.5.3.2Town/ cityMaastricht
    B.5.3.3Post code6229 HX
    B.5.3.4CountryNetherlands
    B.5.6E-mailsecr.nch@mumc.nl
    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 Ketanest-S
    D.2.1.1.2Name of the Marketing Authorisation holderEurocept BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.1Product nameKetanest-S
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Post operative craniotomy pain
    Post operatieve craniotomie pijn
    E.1.1.1Medical condition in easily understood language
    Headache after brainsurgery
    Hoofdpijn na een hersenoperatie
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the effectiveness of s-ketamine as add-on medication to a multimodal pain approach with acetaminophen and opioids compared to placebo with the same multimodal pain approach on the total postoperative opioid consumption, the postoperative pain scores registered with the visual analogue score (VAS) and numeric rating scale (NRS), patient satisfaction, hospital stay and adverse events.
    De effectiviteit van s-ketamine, vergeleken met placebo, als add-on medicament aan een multimodale pijnbenadering met paracetamol en opioïden onderzoeken op de totale opioïd consumptie, de postoperatieve pijn scores geregistreerd met de visual analogue score (VAS) en numeric rating scale (NRS), gezondheids-gerelateerde kwaliteit van leven van de patiënt, psychologische parameters, duur van verblijf in het ziekenhuis en adverse events.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age > 18 years
    - Elective resective surgery for drug-resistant temporal lobe epilepsy
    - Drug-resistant epilepsy, based on: (1) chronic, focal epilepsy; (2) not seizure free with antiepileptic medication; (3) no medication options due to adverse effects
    - Signed informed consent for trial participation
    - Leeftijd > 18 jaar
    - Electieve resectieve chirurgie voor therapieresistente temporaalkwab epilepsie
    - Therapieresistente epilepsie, gebaseerd op: (1) chronische, focale epilepsie; (2) niet-aanvalsvrij zijn met anti-epileptische medicatie; (3) geen opties voor medicatie vanwege nadelige effecten
    - Ondertekend informed consent voor deelname aan de trial
    E.4Principal exclusion criteria
    - Declined informed consent
    - Allergy to any of the trial medications
    - Current chronic pain, such as, but not limiting to, migraine or other headaches.
    - Chronic pain treatment with use of different kinds of pain medication.
    - Alcohol, hard- or soft drug abuses
    - Inability to complete questionnaires or language barrier
    - History of psychiatric complaints for which treatment was performed
    - History of craniotomy or subdural electrode implantation
    - Geweigerd informed consent
    - Allergie voor een van de onderzoeksmedicamenten
    - Chronische pijn, zoals, maar niet beperkt tot, migraine of andere hoofdpijn
    - Chronische pijn behandeling met verschillende soorten pijn medicatie
    - Alcohol, hard- of soft drug misbruik
    - Onvermogen tot het voltooien van een vragenlijst of het hebben van een taalbarrière
    - Psychiatrische klachten waarvoor behandeling is uitgevoerd in de voorgeschiedenis
    - Craniotomie of subdurale elektrode implantatie in de voorgeschiedenis
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint is the total postoperative opioid consumption.
    De primaire uitkomstmaat is de totale postoperatieve opioïd consumptie.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The total postoperative opioid consumption will be measured at the 7th postoperative day with interim measurements at 24, 48, 72 and 96 hours.
    De totale postoperatieve opioïd consumptie zal gemeten worden na de 7e postoperatieve dag met interim metingen na 24, 48, 72 en 96 uur.
    E.5.2Secondary end point(s)
    Secondary endpoints are the postoperative pain scores (VAS+NRS), patient health-related quality of life, psychological parameters, length of hospital stay and adverse events.
    Secundaire uitkomstmaten zijn de postoperatieve pijn scores (VAS+NRS), gezondheids-gerelateerde kwaliteit van leven van de patiënt, psychologische parameters, duur van verblijf in het ziekenhuis en adverse events.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After the operation, all patients will be transferred to the post anaesthesia care unit (PACU), where adverse events and pain scores are registered. Pain scores (VAS+NRS) will be measured at arrival at the PACU, after 1 and 2 hours postoperatively and just before the patient is leaving for the medium care. Additionally patients will fill out a patient diary with pain scores registered at day 1,2,3,4 and 7 postoperatively.
    The patient health-related quality of life and psychological parameters will be measured in the baseline questionnaire prior to the operation and in the follow-up questionnaires completed after 3 and 6 months postoperatively.
    Na de operatie worden alle patiënten overgeplaatst naar de post-anesthesie care unit (PACU), waar adverse events en pijn scores worden geregistreerd. Pijn scores (VAS + NRS) worden gemeten bij aankomst op de PACU, na 1 en 2 uur postoperatief en net voordat de patiënt naar de medium care wordt overgeplaatst. Daarnaast zullen patiënten een patiëntdagboek invullen, waarbij pijnscores geregistreerd worden op dag 1,2,3,4 en 7 postoperatief.
    De gezondheids-gerelateerde kwaliteit van leven van de patiënt en psychologische parameters worden gemeten in de baseline vragenlijst voorafgaand aan de operatie en in de follow-up vragenlijsten na 3 en 6 maanden postoperatief.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    The trial will end when the last included subject has completed and returned the last follow-up questionnaire after 6 months postoperatively. The duration of inclusion of patients for the trial will be 3 years.
    De trial zal eindigen wanneer de laatst geïncludeerde proefpersoon de laatste follow-up vragenlijst na 6 maanden postoperatief heeft ingevuld en ingeleverd. De duur van patiëntinclusie zal 3 jaar zijn.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 62
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state62
    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)
    None
    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 Decision2017-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-14
    P. End of Trial
    P.End of Trial StatusOngoing
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