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    Summary
    EudraCT Number:2014-002547-17
    Sponsor's Protocol Code Number:VU-49636
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-12-01
    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 number2014-002547-17
    A.3Full title of the trial
    Grey matter microglial imaging with [18F]DPA-714 in progressive MS patients
    Beeldvorming van microglia in de grijze stof met [18F]DPA-714 bij progressieve MS patiënten
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Imaging of inflammation in the cortex of the brain in progressive MS patients
    Beeldvorming van ontstekingen in de hersenschors in progressieve MS patiënten
    A.3.2Name or abbreviated title of the trial where available
    [18F]DPA-714 PET in MS
    [18F]DPA-714 PET in MS
    A.4.1Sponsor's protocol code numberVU-49636
    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 SponsorVU University Medical Center
    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 supportVU University Medical Center
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVU University Medical Center
    B.5.2Functional name of contact pointCoordinating investigator
    B.5.3 Address:
    B.5.3.1Street AddressDe Boelelaan 1118
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081 HZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031204440717
    B.5.6E-mailm.hagens1@vumc.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 No
    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 name[18F]DPA-714
    D.3.4Pharmaceutical form Radiopharmaceutical precursor
    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 INN[18F]DPA-714
    D.3.9.3Other descriptive name[18F]DPA-714
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 Yes
    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
    Progressive multiple sclerosis, both primary and secondary progressive
    Progressieve multipele sclerose, zowel primair als secundair progressief
    E.1.1.1Medical condition in easily understood language
    Multipele sclerosis
    Multipele sclerose
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10063401
    E.1.2Term Primary progressive multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10063400
    E.1.2Term Secondary progressive multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10053395
    E.1.2Term Progressive multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of this pilot study is to determine whether uptake op the TSPO radioligand [18f}DPA-714 can be quantified in the cortex and/or hippocampus in vivo to discriminate progressive MS patients from controls.
    De primaire uitkomstmaat is het kwantificeren van het bindingspotentiaal van [18F]DPA-714 in de cortex en hippocampus in vivo en het onderscheid dat hiermee gemaakt kan worden tussen progressieve MS patiënten en gezonde controle personen.
    E.2.2Secondary objectives of the trial
    Secondarily we will determine whether:
    1. Labeled microglial cells co-localize with MRI detected GML and cortical thinning.
    2. Binding in cortex and/or hippocampus correlates with clinical disability and cognitive decline in progressive MS patients.
    1. De co-localisatie van de gelabelde microglia zoals afgebeeld met PET scan en de grijze stof lesies en corticale atrofie zoals gezien op de MRI scan.
    2. De correlatie tussen de hoeveelheid binding van de tracer in de cortex en/of hippocampus en de hoogte van de scores op de neurologische en cognitieve testen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - For the MS patient group: diagnosis primary or secondary progressive MS with EDSS scores 4.0 to 7.5 - 18 to 60 years
    - Written informed consent
    - No immunomodulating or immunosuppressive treatment in previous three months
    - Voor de MS patiënten groep: diagnose primair of secundair progressieve MS met een EDSS score van 4.0 tot 7.5
    - 18 tot 60 jaar
    - Ondertekend informed consent
    - Geen immunomodulerende of immunosuppressieve behandeling in voorafgaande drie maanden
    E.4Principal exclusion criteria
    - Inability to undergo MRI, e.g. metal objects in or around the body, claustrophobia or inability to lie still in the scanner. For the MS patients: contra-indication for gadolinium administration, e.g. previous allergic reaction to gadolinium.
    - Homozygote Ala(147)Thr genotype (low-affinity binders)
    - Significant immune disease other than MS
    - (History of) other relevant neurological disease
    - History of malignancy
    - Known significant cardiac disease
    - Inadequate renal function: creatinine clearance <60 ml/min
    - Loss or donation of blood over 500 mL within four months prior to screening.
    - In male subjects Hb < 8.0 g/dL, in female subjects Hb < 7.0 g/dL
    - Pregnant or breast feeding
    - (History of) alcohol and/or drug abuse
    - Exposure to previous radiation leading to annual cumulative dose of more than 10 mSV if participating in this protocol
    - Use of benzodiazepines within 1 week of the PET scan
    - Niet mogelijk om MRI te ondergaan, zoals bij een metaal voorwerp in het lichaam, claustrophobie of niet sil kunnen liggen in de scanner. Bij de MS patiënten: contra-indicatie voor toedienen gadolinium, zoals een eerdere allergische reactie op gadolinium
    - Homozygoot genotype Ala(147)Thr
    - Significante immuun aandoening anders dan MS
    - (Voorgeschiedenis met) andere relevante neurologische ziekte of aandoening
    - Oncologische voorgeschiedenis
    - Bekende relevante hart aandoening
    - Inadequate nierfunctie: creatinine klaring <60 ml/min
    - Verlies of donatie van bloed van meer dan 500cc in de 4 maanden voorafgaande aan screening
    - Bij mannen Hb <8.0 g/dL, bij vrouwn Hb <7.0 g/dL
    - Zwanger of borstvoeding gevend
    - (Voorgeschiedenis) alcohol en/of drugs misbruik
    - Eerdere stralingsbelasting waardoor de jaarlijkse cumulatieve dosering meer dan 10 mSV zou worden bij deelname aan deze studie
    - Gebruik van een benzodiazepine in de week voorafgaande aan de PET scan
    E.5 End points
    E.5.1Primary end point(s)
    The main study parameter is the [18F]DPA-714 binding potential (BP) which will be assessed in PPMS and SPMS patients and healthy control subjects with validated tracer kinetic models. BP is a measurement of microglial activation.
    De primaire uitkomstmaat is het bindings potentiaal (BP) van [18F]DPA-714 geanalyseerd in de primaire en secundair progressieve MS patiënten en de gezonde controles middels gevalideerde tracer kinetiek modellen. BP is hierin een maat van microglia activatie.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The BP will be assessed from the data collected during the 60 minute [18F]DPA-714 PET scan. Each patient and control subject will undergo one PET scan and therefore one administration of the tracer.
    Het BP zal geanalyseerd worden aan de hand van de data verzameld tijdens de 60 minute durende [18F]DPA-714 PET scan. Elke patiënt en gezonde controle zal één PET scan ondergaan en daarbij een eenmalige toediening van de tracer.
    E.5.2Secondary end point(s)
    - The relation between [18F]DPA-714 BP in the cerebral cortex and/or hippocampus and MRI detected grey matter lesions and cortical thinning.
    - The relation between [18F]DPA-714 BP in the cerebral cortex and/or hippocampus and clinical disability and cognitive decline in progressive MS patients as measured with the Expanded Disability Status Scale (EDSS), Multiple Sclerosis Functional Composite (MSFC) and Symbol Digit Modalities Test (SDMT).
    - De relatie tussen [18F]DPA-714 BP in de cerebrale cortex en/of hippocampus en de MRI gedetecteerd grijze stof lesies en cortical atrofie.
    - De relatie tussen [18F]DPA-714 BP in de cerebrale cortex en/of hippocampus en klinische en cognitieve uitkomstmaten gemeten op de Expanded Disability Status Scale (EDSS), Multiple Sclerosis Functional Composite (MSFC) and Symbol Digit Modalities Test (SDMT).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Each patient and control will have three visits in a fixt order: 1. screening session 2. MRI scan 3. PET scan.
    The end points will be evaluated after completion of these three visits.
    Elke patiënt en gezonde controle heeft drie visits in een vaste volgorde: 1. screening sessie 2. MRI scan 3. PET scan.
    De uitkomstmaten zullen geanalyseerd worden na voltooiing van alle drie de visits.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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 No
    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
    LVLS
    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: 20
    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 Yes
    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 state20
    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)
    No special post trial treatment is planned. In case of adverse events or withdrawel during the trial, the patient will be contacted after ending the trial by the coordinating investigator, either in person at the neurology outpatient clinc or by telephone.
    Er is geen speciale post trial behandeling gepland. In het geval van een adverse event of tussentijds stoppen met de studie, zal de patiënt na beëindiging van de studie gecontacteerd worden door de coördinerend onderzoek, of persoonlijk op de polikliniek neurologie of telefonisch.
    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 Decision2014-12-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-01-21
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    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
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