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    Summary
    EudraCT Number:2021-003716-12
    Sponsor's Protocol Code Number:RHNIA-001-2021
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-10-06
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2021-003716-12
    A.3Full title of the trial
    S-ketamine for cortical spreading depolarisation in patients with severe acute brain injury
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The anesthetic ketamine as treatment of patients with severe acute brain injury
    Bedøvemidlet ketamin som behandling af patienter med svær akut hjerneskade
    A.3.2Name or abbreviated title of the trial where available
    KETA-BID
    A.4.1Sponsor's protocol code numberRHNIA-001-2021
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05095857
    A.5.4Other Identifiers
    Name:Regional Committee for Health Research Ethics of tNumber:H-21056972
    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 SponsorRigshospitalet
    B.1.3.4CountryDenmark
    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 supportNeurokirurgisk forskningspulje (at the Department of Neurosurgery)
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportSnedkermester Sophus Jacobsen og hustru Astrid Jacobsens Foundation
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportThe A.P. Møller Foundation
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportKnud og Edith Eriksens Mindefond
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportRigshospitalets 3-årigt ph.d.-stipendium
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportThe Danish Victims Foundation
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportThe Novo Nordisk Foundation
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportDagmar Marshall's Foundation
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportDASAIM Research Initiative 2021
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRigshospitalet
    B.5.2Functional name of contact pointDepartment of Neuroanaesthesiology
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4535455982
    B.5.6E-mailtrine.hjorslev.andreasen@regionh.dk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Esketamine
    D.2.1.1.2Name of the Marketing Authorisation holderOrifarm
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameEsketamine
    D.3.2Product code 30994
    D.3.4Pharmaceutical form Injection/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 INNEsketamine
    D.3.9.3Other descriptive nameESKETAMINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB25811
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 placeboInjection/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
    Severe acute brain injury caused by aneurysmal subarachnoid hemorrhage, spontaneous intracerebral hemorrhage or traumatic brain injury.
    E.1.1.1Medical condition in easily understood language
    Severe brain injury after a brain hemorrhage caused by either trauma to the head, rupture of a brain aneurysm, or a spontaneous bleeding in the brain tissue.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10018061
    E.1.2Term General anesthesia
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10070731
    E.1.2Term Electrocorticography
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10056389
    E.1.2Term Brain damage
    E.1.2System Organ Class 100000004852
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10019529
    E.1.2Term Hemorrhage brain
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This pilot and feasibility trial – the KETA-BID trial – aims investigate the efficacy and safety of S-ketamine on the occurrence of cortical spreading depolarisations and the feasibility of the setup. More specifically, the KETA-BID trial investigates the efficacy of S-ketamine in those where cortical spreading depolarisations persist despite physiological optimisation.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this trial is investigate the safety of using S-ketamine for patients with severe acute brain injury by investigating the rate of adverse events and adverse reactions after randomisation and throughout the intervention period, and to examine functional outcome at 6 months after ictus of brain injury.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age ≥ 18 years.
    • Admitted to the NICU with a diagnosis of traumatic brain injury, aneurysmal subarachnoid hemorrhage or spontaneous intracerebral hemorrhage.
    • Planned for surgery with a craniotomy or craniectomy.
    • Expected to continue sedation and mechanical ventilation after surgery.
    E.4Principal exclusion criteria
    • Patient and next of kin do not read or understand spoken Danish.
    • Known allergy to S-ketamine (the active pharmaceutical ingredient or the excipients).
    • Wake-up call to occur immediatly after surgery.
    • Pregnancy (all female participants aged ≤ 50 years will have a blood hCG to control for pregnancy).
    • Active anti-psychotic treatment before admission.
    • Current abuse of ketamine.
    E.5 End points
    E.5.1Primary end point(s)
    Occurrence of cortical spreading depolarisations per hour of ECoG monitoring after randomisation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From randomisation (i.e. start of treatment with S-ketamine or placebo) until end of ECoG monitoring.
    E.5.2Secondary end point(s)
    • Rate of adverse events and adverse reactions
    • Functional outcome (using modified Rankin Scale) at 6 months after ictus of brain injury.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Rate of adverse events and adverse reactions: from randomisation and throughout the intervention period.
    Functional outcome (using modified Rankin Scale): at 6 months after ictus of brain injury.
    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 Yes
    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
    LVLS
    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 months
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-10-06. Yes
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Participants will be incapable of giving consent due to the severity of the brain injury causing impaired consciousness.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state160
    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 Decision2021-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-08-24
    P. End of Trial
    P.End of Trial StatusOngoing
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