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    Summary
    EudraCT Number:2019-000247-27
    Sponsor's Protocol Code Number:ZX-2018-LBT999-DATTEP-3
    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:2019-03-05
    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 number2019-000247-27
    A.3Full title of the trial
    Non-inferiority study of the molecular imaging of dopamine transporters using [123I]-FP/CIT-SPECT and [18F] LBT-999-PET to distinguish between Parkinson’s Disease and Essential Tremor.
    Etude de non infériorité entre l’imagerie moléculaire des transporteurs de la dopamine obtenue par le marqueur [123I]-FP-CIT en TEMP et le biomarqueur [18F] LBT-999 en TEP dans le diagnostic différentiel entre Parkinson et Tremblement Essentiel.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to demonstrate an at least equivalent performance of a new test in brain imaging test compared to the reference examination to establish the differential diagnosis between Parkinson's Disease and Essential Tremor.
    Etude visant à démontrer une performance au moins équivalente d'un nouvel examen d'imagerie du cerveau par rapport à l’examen de référence pour établir le diagnostic différentiel entre la maladie de Parkinson et le tremblement essentiel.
    A.3.2Name or abbreviated title of the trial where available
    DATTEP
    DATTEP
    A.4.1Sponsor's protocol code numberZX-2018-LBT999-DATTEP-3
    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 SponsorZIONEXA
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportZionexa
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationZIONEXA
    B.5.2Functional name of contact pointAmandine COCHE
    B.5.3 Address:
    B.5.3.1Street Address4, allée du groupe Nicolas Bourbaki
    B.5.3.2Town/ cityAubière
    B.5.3.3Post code63170
    B.5.3.4CountryFrance
    B.5.4Telephone number+33473190242
    B.5.6E-mailamandine.coche@zionexa.com
    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 DaTSCAN 74 MBq/ml solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderGE Healthcare Limited
    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.3.4Pharmaceutical 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 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.IMP: 2
    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.3.2Product code [18F] LBT-999
    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 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
    Patients suffering from an essential tremor or with Parkinson's disease.
    Patients souffrant d’un tremblement essentiel ou présentant une maladie de Parkinson
    E.1.1.1Medical condition in easily understood language
    Parkinson's disease: progressive loss of neurons responsible for tremors and slow movements.
    Essential tremor: neurological disease of abnormal movements.
    Maladie de Parkinson: perte progressive des neurones responsables de tremblements et de lenteur dans les mouvements.
    Tremblement essential : maladie neurologiques des mouvements anormaux.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061536
    E.1.2Term Parkinson's disease
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10015496
    E.1.2Term Essential tremor
    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
    Demonstrate an at least equivalent performance of [18F] LBT-999-PET with respect to [123I]-FP-CIT-SPECT in visual analysis for the differential diagnosis of patients suffering of Essential Tremor or Parkinson’s Disease (visual/qualitative analysis)
    L’objectif principal de l’étude est la mise en évidence d’une performance au moins équivalente de l’imagerie [18F] LBT-999 en TEP par rapport au [123I]-FP-CIT en TEMP en analyse visuelle dans le diagnostic différentiel entre patients présentant une maladie de Parkinson typique comparativement à des patients atteints de tremblement essentiel.
    E.2.2Secondary objectives of the trial
    Calculate the threshold value with [18F] LBT-999-PET (in quantitative analysis) that best distinguish Parkinson’s Disease from Essential Tremor
    - Show that when using the [18F] LBT-999-PET compared with [123I]-FP-CIT-SPECT, these are achieved:
    (i) Improvement of patient’s comfort during image acquisition
    (ii) Improvement of confidence level during image interpretation
    (iii) Equivalent performance of [18F] LBT-999-PET with respect to [123I]-FP/CIT-SPECT for the differential
    diagnosis of patients suffering of Essential Tremor or Parkinson’s Disease (quantitative analysis)
    (iv) Improvement of the precision of quantification
    - Evaluate patient tolerance to [18F] LBT-999
    - Dosimetry evaluations for patients and caregivers
    a)Déterminer la valeur seuil (en analyse quantitative) par l’imagerie [18F] LBT-999 en TEP qui discrimine le mieux les patients présentant une maladie de Parkinson typique comparativement à des patients atteints de tremblement essentiel ce qui correspond à l’adaptation du logiciel Datsoft 3D de quantification connu, aux spécificités du LBT
    b)Montrer qu’il existe avec l’imagerie [18F] LBT-999 (TEP) comparativement au [123I]-FP-CIT (TEMP)
    - amélioration du confort du patient (conditions d’examen)
    - amélioration du niveau de confiance dans l’interprétation des images
    - performance équivalente de l’imagerie [18F] LBT-999 en TEP par rapport au [123I]-FP-CIT en TEMP en analyse quantitative dans le diagnostic différentiel entre patients présentant une maladie de Parkinson typique comparativement à des patients atteints de tremblement essentiel
    - amélioration de la précision de quantification
    c) Evaluer tolérance du [18F] LBT-999
    d) Evaluer dosimétrie pour patients et personnel soignant
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patient aged 35 to 80 (male or female)
    • Patient:
    - suffering from an essential tremor according to the 2000 criteria of Elble (excluding head's tremor)
    - or with Parkinson's disease according to UKPDSBB criteria
    • Patient whose diagnosis is more than 18 months old
    • Patient affiliated with a health protection system or beneficiary of such a system
    • Patient who has received complete information on the organization of the research and signed his informed consent
    • Patient âgé de 35 à 80 ans (homme ou femme)
    • Patient :
    - souffrant d’un tremblement essentiel selon les critères de 2000 de Elble (hors tremblement du chef)
    - ou présentant une maladie de Parkinson selon les critères de l’UKPDSBB
    • Patient dont le diagnostic date de plus de 18 mois
    • Patient affilié à un régime de sécurité sociale ou bénéficiaire d’un tel régime
    • Patient ayant reçu l’information complète sur l’organisation de la recherche et ayant signé son consentement éclairé
    E.4Principal exclusion criteria
    • Patient with atypical non-idiopathic parkinsonian syndrome (multisystematous atrophy, progressive supranuclear palsy, etc.)
    • Patient treated with deep brain stimulation
    • Patient suffering from abnormal functional psychogenic movements
    • Patient with severe and progressive psychiatric disorders
    • Patient with disabling dyskinesia or essential tremor, incompatible with performing imaging exams
    • Patient who had an ionizing examination at the cerebral level less than 3 months old
    • Person with a contraindication to performing PET or SPECT imaging:
    o Patient with claustrophobia
    o Patient refusing to be informed in case of abnormalities detected during imaging examinations
    o Patients treated with amphetamines, benzatropine, amfebutamone, cocaine, mazindol, methylphenidate, phentermine or sertraline
    o Person with a known allergy to the active substance or to any of the excipients of the evaluated product or reference product or to potassium iodide
    • A woman of childbearing potential who does not have effective contraception according to investigator judgment
    • Patient unable to sign the informed consent
    • Patient participating to a protocol or period of exclusion from a protocol
    • Patient who received benefits over € 4,500 in the last 12 months prior to inclusion in clinical studies
    • Patient in exclusion period in national volunteer file during which he can not participate in another clinical study
    • Patient not affiliated to a health protection system
    • Patient refusing to participate
    • Persons referred to in Articles L. 1121-5 to L. 1121-8 and L1122-2 of the French Public Health Code:
    o Pregnant or lactating woman
    o Person deprived of liberty by a judicial or administrative decision,
    o Person under psychiatric care
    o Person admitted to a health or social institution for purposes other than research
    o Person who is the subject of a legal protection measure (tutelage, guardianship, safeguard of justice)
    o Major person unable to express consent and who is not subject to a legal protection measure
    • Patient souffrant d’un syndrome parkinsonien non idiopathique atypique (atrophie multisystématisée, paralysie supranucléaire progressive, etc.)
    Patient traité par stimulation cérébrale profonde
    • Patient souffrant de mouvements anormaux psychogènes fonctionnels
    • Patient présentant des troubles psychiatriques sévères et évolutifs
    • Patient présentant des dyskinésies invalidantes ou un tremblement essentiel, incompatibles avec la réalisation des examens en imagerie
    • Patient ayant eu un examen ionisant au niveau cérébral datant de moins de 3 mois
    • Personne présentant une contre-indication à la réalisation d’une imagerie en TEP ou TEMP :
    o Patient présentant une claustrophobie
    o Patient refusant d’être informés en cas d’anomalies décelées lors des examens en imagerie
    o Patient traité par amphétamines, benzatropine, amfébutamone, cocaïne, mazindol, méthylphénidate, phentermine ou sertraline
    o Personne présentant une allergie connue à la substance active ou à l’un des excipients du produit évalué ou du produit de référence ou à l’iodure de potassium
    • Femme en âge de procréer ne disposant pas de moyen de contraception efficace selon l’avis de l’investigateur
    • Patient en incapacité de signer le consentement éclairé
    • Patient participant à un protocole ou en période d’exclusion d’un protocole
    • Patient ayant reçu des indemnités supérieures à 4500€ au cours des 12 derniers mois précédent l’inclusion dans le cadre d’études cliniques
    • Patient en période d’exclusion dans le fichier national des volontaires au cours de laquelle il ne peut participer à une autre étude clinique
    • Patient non affilié à un régime de sécurité sociale
    • Patient refusant de participer
    • Personnes visées aux articles L. 1121-5 à L. 1121-8 et L1122-2 du code de la santé publique :
    o Femme enceinte ou allaitante
    o Personne privée de liberté par une décision judiciaire ou administrative,
    o Personne faisant l'objet de soins psychiatriques
    o Personne admise dans un établissement sanitaire ou social à d'autres fins que celle de la recherche
    o Personne majeure faisant l'objet d'une mesure de protection légale (tutelle, curatelle, sauvegarde de justice)
    o Personne majeure hors d'état d'exprimer son consentement et qui ne fait pas l'objet d'une mesure de protection juridique
    E.5 End points
    E.5.1Primary end point(s)
    Sensitivity and specificity of each imaging method on the diagnosis of normal or pathological examination on the visual analysis by 5 independent readers interpreting a minimum of 200 [123I]-FP/CIT-SPECT per year, without knowing the clinical diagnosis
    La sensibilité et la spécificité de chaque méthode sur le diagnostic d’examen normal ou pathologique basé sur l’analyse visuelle par 5 médecins nucléaires relecteurs indépendants interprétant un minimum de 200 [123I]-FP-CIT en TEMP par an, et en insu du diagnostic clinique.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The independent review committee will analyse the PET and TEMP images blindly. These analyses will be done by batch of 25 patients.
    Le comité de relecture d’experts indépendant analysera les images TEP et TEMP en aveugle. Ces analyses se feront par lot de 25 patients.
    E.5.2Secondary end point(s)
    - [18F] LBT-999-PET threshold for distinguishing Parkinson’s Disease from Essential Tremor
    - (i) Patient’s comfort will be measured using the visual analogic scale for each type of image acquisition (i.e. PET and SPECT), except for patient with entire body dosimetry
    - (ii) Diagnostic confidence in the interpretation of MRP fixation for the caudate nuclei and putamens of each patient for each type of examination (SPECT and PET). This trust will be assessed by each reviewer using criteria scales on image quality and interpretation trust (Poor, moderate, almost perfect)
    - (iii) Sensitivity and specificity of each diagnostic method of examination by quantified analysis
    - (iv) Precision of quantification for each method of image acquisition
    - Adverse events during image acquisition
    - Dosimetry measurements for [18F] LBT-999 patients and their caregivers
    a) Seuil de discrimination du LBT entre les patients parkinsoniens et les trembleurs essentiels
    b)
    i. Confort du patient à l’aide d’une échelle visuelle analogique (EVA) pour chaque type d’examen (TEP ou TEMP). L’EVA ne sera pas réalisée pour les patients participants à la dosimétrie corps entier.
    ii. Confiance diagnostique dans l’interprétation de la fixation des MRP pour les noyaux caudés et les putamens de chaque patient pour chaque type d’examen (TEMP et TEP). Cette confiance sera évaluée par chaque relecteur à l’aide d’échelles de critères sur la qualité des images et la confiance d’interprétation.
    iii. Sensibilité et la spécificité de chaque méthode diagnostique d’examen par l’analyse quantifiée.
    iv. Précision de la quantification pour les deux types d’examens (ajustée sur l’âge).
    c) Evènements indésirables lors des examens
    d) Mesure des valeurs dosimétriques de la TEP [18F] LBT-999 patients et personnel soignant
    E.5.2.1Timepoint(s) of evaluation of this end point
    Data collected during V1 and V2 visits (SPECT/PET).
    Données collectées aux visites V1 et V2 (TEMP/TEP).
    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 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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned9
    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
    Dernière visite du dernier patient
    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 months2
    E.8.9.1In the Member State concerned days0
    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.1.3Elderly (>=65 years) Yes
    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 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 state112
    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
    Aucun
    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 Decision2021-03-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-09
    P. End of Trial
    P.End of Trial StatusOngoing
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