Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2017-003930-10
    Sponsor's Protocol Code Number:KEKU1
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-02-15
    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 ConcernedFrance - ANSM
    A.2EudraCT number2017-003930-10
    A.3Full title of the trial
    KETAMINE'S EFFICIENCY IN THE TREATMENT OF CHRONIC PAIN WITH INFLAMMATORY COMPONENT: EXPLORING THE KYNURENIN PATHWAYS.
    A controlled, placebo-controlled, double-blind trial.
    EFFICACITÉ DE LA KÉTAMINE DANS LE TRAITEMENT DES DOULEURS CHRONIQUES A COMPOSANTE INFLAMMATOIRE : EXPLORATION DES VOIES DE LA KYNURENINE.
    Un essai contrôlé, contre placebo, en double aveugle.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of Ketamine, in the treatment of chronic pain with inflammatory component, evaluated in a double-blind, placebo-controlled trial.
    Efficacité de la Kétamine, dans le traitement des douleurs chroniques à composante inflammatoire, évaluée dans un essai, contrôlé contre placebo, en double aveugle.
    A.3.2Name or abbreviated title of the trial where available
    KEKU1
    A.4.1Sponsor's protocol code numberKEKU1
    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 SponsorRecherche et enseignement en douleur, anesthesie reanimation
    B.1.3.4CountryFrance
    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 supportINSERM U987
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRecherche et enseignement en douleur, Anesthesie Réanimation
    B.5.2Functional name of contact pointCyril QUEMENEUR
    B.5.3 Address:
    B.5.3.1Street Address139 Rue du Faubourg Saint Antoine
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75011
    B.5.3.4CountryFrance
    B.5.4Telephone number+330681193981
    B.5.6E-mailc.quemeneur@gmx.com
    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 KETAMINE KETAMINE PANPHARMA (50mg/5mL), Solution injectable IV-IM
    D.2.1.1.2Name of the Marketing Authorisation holderPANPHARMA
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 injection/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 injection/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
    The population selected is a spinal cord injury population with central neuropathic pain at the lesional or sub-lesion level, chronically (for more than three months) Adult, spinal cord injury (SCI), with <C5 involvement, presenting with chronic neuropathic pain ( DN), in lesional territory or under lesion. 2 groups: BM with DN with ulcer pressure (inflammation factor) BM with DN without ulcer pressure (without inflammation)
    La population choisie est une population de blessés médullaires présentant des douleurs neuropathiques centrales au niveau lésionnel ou sous lésionnel, de façon chronique (depuis plus de trois mois) Adulte, blessé médullaire (BM), avec atteinte < C5, présentant des douleurs neuropathiques chroniques(DN), en territoire lésionnel ou sous lésionnel.
2 groupes :BM avec DN avec escarre (inflammation associée) BM avec DN sans escarre (pas de facteur inflammatoire)
    E.1.1.1Medical condition in easily understood language
    Medullary wounds with refractory chronic neuropathic pain with inflammatory associated or not. Study of the effectiveness of ketamine on these different types of pain.
    Blessés médullaires atteints de douleurs neuropathiques chroniques refractaires avec caractère inflammatoire associé ou non. Etude de l'efficacité de la kétamine sur ces différents types de douleurs.
    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 show improved clinical efficacy of ketamine in chronic pain in patients with an inflammatory component
    Montrer une meilleure efficacité clinique de la kétamine dans la douleur chronique chez des patients présentant une composante inflammatoire
    E.2.2Secondary objectives of the trial
    To explore the anti-inflammatory activity of ketamine through the Kynurenine pathway.
    Explorer l'activité anti-inflammatoire de la kétamine par le biais de la voie des Kynurénines.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adults speaking and understanding French
    - presenting chronic neuropathic pain as defined by IASP
    - Painful intensity> or = to 6/10 during the week preceding the inclusion
    - Medullary lesion, whatever the origin (traumatic, degenerative, tumoral, postoperative), responsible for paraplegia in a chronic state.
    - Able to give informed consent, after clear, fair and appropriate information
    - Having given their consent by a written consent signature.
    - Adultes parlant et comprenant le Français
    - Présentant des douleurs neuropathiques chroniques, selon la définition de l’IASP
    - Intensité douloureuse > ou = à 6 / 10 au cours de la semaine précédant l’inclusion
    - Lésion médullaire quelques soit l’origine (traumatique, dégénérative, tumorale, post opératoire), responsable d’une paraplégie à un état chronique.
    - Capable de donner leur consentement éclairé, après une information claire, loyale et appropriée
    - Ayant donné leur accord par une signature de consentement écrit.
    E.4Principal exclusion criteria
    - Participation in another interventional trial, or participation in another trial that has been interrupted for less than 3 months.
    - Patient under legal protection
    - Pregnancy or breastfeeding
    - Refusal to sign the consent
    - Cardiovascular diseases associated in particular with disorders of rhythm and severe cardiac insufficiency, coronary insufficiency, discovered on examination, on ECG or by biological balance or known.
    - unstabilized HTA> 180/100 mmHg
    - Severe hepatic and / or renal hepatic insufficiency.
    - Participation à un autre essai interventionnel, ou participation à un autre essai interrompu depuis moins de 3 mois.
    - Patient sous protection juridique
    - Grossesse ou allaitement en cours
    - Refus de signature du consentement
    - Pathologies cardio-vasculaires associées en particulier à des troubles du rythme et insuffisances cardiaques sévères, insuffisance coronarienne, découverts à l’examen, sur ECG ou par bilan biologique ou connus.
    - HTA non stabilisée > 180/100 mmHg
    - Insuffisance hépato cellulaire et / ou rénale sévères.
    E.5 End points
    E.5.1Primary end point(s)
    Decrease by more than 30% the intensity of neuropathic pain evaluated at the moment on a numerical scale of 10 points at H4. Comparison of groups two by two.
    Diminution de plus de 30 % l’intensité de la douleur neuropathique évaluée à l’instant sur une échelle numérique de 10 points à H4. Comparaison des groupes deux à deux.
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 hours after infusion
    4 heures après la fin de la perfusion
    E.5.2Secondary end point(s)
    NPSI score at H1, H6, J1, J4, J7
    Sub score of NPSI; H1, H6, J1, J4, J7
    Depression score HADS J0, J1, J7
    Painful surface evaluated on cartography H1, H4, J1, J4, J7

    Blood tests in pre-administration of Ketamine and H6 after administration of: serotonin (5-HT), kynurenine (KYN), indoleamine 2,3-dioxygenase 1 (IDO1) activity (KYN / TRP ratio), kynurenic acid (KA) and quinolinic acid (QA), as well as 3 proinflammatory cytokines IL-1β, IL-6, and TNF-α
    Critères d’évaluation secondaires

    Score de NPSI à H1, H4, J1, J4, J7
    Sous score du NPSI ; H1, H4, J1, J4, J7
    Score de dépression HADS J0, J1, J7
    Surface douloureuse évalué sur cartographie H1, H4, J1, J4, J7

    Dosages sanguins en pré administration de Kétamine puis à H4 après administration de : serotonine (5-HT), kynurenine (KYN), indoleamine 2,3-dioxygenase 1 (IDO1) activity (ratio KYN/TRP), kynurenic acid (KA) and quinolinic acid (QA), ainsi que 3 cytokines proinflammatoires IL-1β, IL-6, and TNF-α
    E.5.2.1Timepoint(s) of evaluation of this end point
    Hours 1 and 4
    Day 1 4 and 7
    H1,H4,J1,J4,J7
    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 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    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 No
    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

    Our study will end after the last evaluation of the last topic included at J7 of the last included patient.
    48 patients will be included in our trial.
    The expected duration according to our calculations is 6 months.
    Notre étude prendra fin après la dernière evaluation du dernier sujet inclus soit à J7 du dernier patient inclus.
    48 patients seront inclus dans notre essai.
    La durée prévisible d'après nos calculs est de 6 mois.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state48
    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

    Patients will be monitored as part of the follow-up and treatment of their refractory neuropathic pain in our specialized center.
    Aucun
    Les patients feront l'objet d'un suivi standard dans le cadre du suivi et du traitement de leurs douleurs neuropathiques refractaires dans notre centre spécialisée.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation INSERM U987
    G.4.3.4Network Country France
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-01-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-10
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun Apr 28 17:59:09 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA