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    Summary
    EudraCT Number:2021-000640-21
    Sponsor's Protocol Code Number:KetCRPS-2
    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:2021-08-03
    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 number2021-000640-21
    A.3Full title of the trial
    Long-term pain modulation by intravenous esketamine in Complex Regional Pain Syndrome: a non-inferiority study
    Lange-termijn pijnmodulatie met intraveneuze esketamine bij Complex Regionaal Pijnsyndroom: een non-inferioriteitsonderzoek
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Esketamine via the bloodstream for Complex Regional Pain Syndrome
    Esketamine via de bloedbaan bij Complex Regionaal Pijn Syndroom
    A.4.1Sponsor's protocol code numberKetCRPS-2
    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 SponsorCenter for Pain Medicine, Erasmus MC
    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 supportErasmus MC
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus MC
    B.5.2Functional name of contact pointTom Mangnus
    B.5.3 Address:
    B.5.3.1Street AddressDr. Molewaterplein 40
    B.5.3.2Town/ cityROTTERDAM
    B.5.3.3Post code3015GD
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31107040704
    B.5.6E-mailt.mangnus@erasmusmc.nl
    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 Ketanest-S
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer B.V.
    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 nameEsketamine
    D.3.2Product code Esketamine
    D.3.4Pharmaceutical form Solution for injection
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Complex Regional Pain Syndrome
    Complex Regionaal Pijn Syndroom
    E.1.1.1Medical condition in easily understood language
    Complex Regional Pain Syndrome
    Complex Regionaal Pijn Syndroom
    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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of this study is to assess whether a series of esketamine infusions, once a week for a period of six weeks, in a day treatment setting, is non-inferior to the standard treatment of a 6-day clinical admission of continuous esketamine administration.
    Het doel van deze studie is om te beoordelen of een reeks esketamine-infusies, eenmaal per week gedurende een periode van zes weken, in een dagbehandeling, non-inferieur is aan de standaardbehandeling van een 6-daagse klinische opname met continue toediening van esketamine.
    E.2.2Secondary objectives of the trial
    • Number and severity of intervention related adverse events in each of the esketamine administration regimens
    • To assess protocol deviations due to logistical problems for each of the administration regimens
    • Physiological measures: Questionnaires COMPACT (Core Outcome Measurement set for complex regional PAin syndrome Clinical sTudies)
    • Objective measures: Quantitative Sensory Testing (QST), thermography, serum levels and cellular immunity samples
    • Dose reduction of pain medication at follow up


    • Aantal en ernst van interventiegerelateerde bijwerkingen in elk van de toedieningsschema's van esketamine
    • Het beoordelen van protocolafwijkingen als gevolg van logistieke problemen voor elk van de toedieningsregimes
    Fysiologische metingen: vragenlijsten COMPACT (Core Outcome Measurement set voor complexe regionale PAin-syndroom klinische onderzoeken)
    • Objectieve maatregelen: kwantitatieve sensorische tests (QST), thermografie, serumniveaus en cellulaire immuniteitsmonsters
    • Dosisverlaging van pijnmedicatie bij follow-up
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a subject must meet all of the following criteria:
    - Age ≥ 18 years.
    - Meeting or having met the Budapest Criteria of CRPS (Harden, 2010)
    - Willing and capable to participate in the study.
    - CRPS in one upper extremity and/or CRPS in one lower extremity
    - Treatment in an elective setting.
    Om in aanmerking te komen voor deelname aan dit onderzoek, moet een proefpersoon aan alle volgende criteria voldoen:
    - Leeftijd ≥ 18 jaar.
    - Voldoen aan of hebben voldaan aan de CRPS-criteria van Boedapest (Harden, 2010)
    - Bereid en in staat om deel te nemen aan de studie.
    - CRPS in één bovenste extremiteit en / of CRPS in één onderste extremiteit
    - Behandeling in een electieve setting.
    E.4Principal exclusion criteria
    A potential subject who meets any of the following criteria will be excluded from participation in this study:
    - Inadequate comprehension of the Dutch language
    - Pregnancy
    - Unstable angina, poorly controlled hypertension, high-risk coronary vascular disease
    - Severe liver disease
    - Elevated intracranial pressure
    - Elevated intraocular pressure, acute globe injury, or glaucoma
    - Thyrotoxicosis
    - Pheochromocytoma
    - Active substance abuse
    - Psychosis or delirium
    - Refusal or inability to consent
    Een potentiële proefpersoon die aan een van de volgende criteria voldoet, wordt uitgesloten van deelname aan dit onderzoek:
    - Onvoldoende begrip van de Nederlandse taal
    - Zwangerschap
    - Instabiele angina pectoris, slecht gecontroleerde hypertensie, hoog risico coronaire vaatziekte
    - Ernstige leverziekte
    - Verhoogde intracraniale druk
    - Verhoogde intraoculaire druk, acuut oogbolletsel of glaucoom
    - Thyrotoxicose
    - Feochromocytoom
    - Misbruik medicijnen/drugs
    - Psychose of delier
    - Weigering of onvermogen om toestemming te geven
    E.5 End points
    E.5.1Primary end point(s)
    Pain intensity measured by Numerical Rating Scale (NRS):
    - The average NRS score of the last 24 hours
    - The current NRS score reflecting the pain intensity at the moment when asked
    Pijnintensiteit gemeten met pijnscore, numerieke beoordelingsschaal (NRS):
    - De gemiddelde NRS-score van de afgelopen 24 uur
    - De huidige NRS-score die de pijnintensiteit weergeeft op het moment dat daarom wordt gevraagd
    E.5.1.1Timepoint(s) of evaluation of this end point
    T0= Baseline, before ketamine administration
    T1= After last esketamine treatment
    T2= Three months after esktemine administration
    T0 = ​​Baseline, vóór toediening van ketamine
    T1 = Na de laatste behandeling met esketamine
    T2 = drie maanden na toediening van esktemine
    E.5.2Secondary end point(s)
    - To assess protocol deviations due to logistical problems for each of the administration regimens: premature termination (due to i.e. bed capacity problems), waiting time for therapy (weeks) and compliance of the patients.
    - Number and severity of intervention related adverse events: Psychomimetic (dysphoria, hallucinations, nightmares and vivid dreams), blurry vision or diplopia, nausea and / or vomiting, hepatic toxicity, headache and dislocation of peripheral intravenous catheter
    - Objectively measured effects of each of the administration regimens on the inflammation; serum levels of sIL-2R and sCD163 will be detected with Enzyme Linked Immunosorbent Assay (ELISA) as measures for T-lymhpocyte and macrophage activation, respectively. In addition, T cell populations and monocyte populations will be identified using flow cytometry.
    - To assess the sensory-discriminative dimensions of pain before and after ketamine treatment; Quantitative Sensory Testing
    - Objectively measured effects of each of the administration regimens on symptoms vasomotor disturbances; Thermography
    - Dose reduction of pain medication at follow after three months (yes/no)
    - CRPS severity score {Harden, 2010 #184}. CRPS symptoms and signs based on the Budapest diagnostic clinical criteria.
    - Het beoordelen van protocolafwijkingen als gevolg van logistieke problemen voor elk van de toedieningsregimes: voortijdige beëindiging (vanwege bijvoorbeeld problemen met de capaciteit van het bedden), wachttijd voor therapie en therapietrouw van de patiënten.
    - Aantal en ernst van interventiegerelateerde bijwerkingen: psychomimetisch (dysforie, hallucinaties, nachtmerries en levendige dromen), wazig zien of diplopie, misselijkheid en / of braken, levertoxiciteit, hoofdpijn en ontwrichting van perifere intraveneuze katheter
    - Objectief gemeten effecten van elk van de toedieningsregimes op de ontsteking; serumniveaus van sIL-2R en sCD163 zullen worden gedetecteerd met Enzyme Linked Immunosorbent Assay (ELISA) als metingen voor respectievelijk T-lymhpocyten- en macrofaagactivering. Bovendien zullen T-celpopulaties en monocytenpopulaties worden geïdentificeerd met behulp van flowcytometrie.
    - De sensorisch-discriminerende dimensies van pijn voor en na ketamine-behandeling beoordelen; Kwantitatieve sensorische tests
    - Objectief gemeten effecten van elk van de toedieningsregimes op symptomen van vasomotorische stoornissen; Thermografie
    - Dosisverlaging van pijnmedicatie na drie maanden volgen (ja / nee)
    - CRPS-ernstscore {Harden, 2010 # 184}. CRPS-symptomen en symptomen op basis van de diagnostische klinische criteria van Boedapest.
    E.5.2.1Timepoint(s) of evaluation of this end point
    T0= Baseline, before ketamine administration
    T1= After last esketamine treatment
    T2= Three months after esktemine administration
    T0 = ​​Baseline, vóór toediening van ketamine
    T1 = Na de laatste behandeling met esketamine
    T2 = drie maanden na toediening van esktemine
    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 Yes
    E.6.13.1Other scope of the trial description
    inpatient vs outpatient treatment
    poliklinische dagbehandeling vs klinische opname in ziekenhuis
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Esketamine in dagbehandeling vs esketamine in klinische ziekenhuisopname
    esketamine in outpatient daytreatment vs esketamine inpatient treatment
    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
    Last visit of the last subject undergoing the trial.
    Laatste bezoek van de laatste proefpersoon die de behandeling ondergaat.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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: 60
    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 state60
    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)
    Regular treatment according to Dutch CRPS guidelines
    Regulier behandeling volgens Nederlandse CRPS richtlijn
    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 Decision2021-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-10
    P. End of Trial
    P.End of Trial StatusOngoing
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