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    The EU Clinical Trials Register currently displays   36119   clinical trials with a EudraCT protocol, of which   5940   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2008-003982-21
    Sponsor's Protocol Code Number:P080402
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-01-14
    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 number2008-003982-21
    A.3Full title of the trial
    Etude des transporteurs de la dopamine et de la sérotonine en imagerie TEMP utilisant les radiopharmaceutiques 123I-FP-CIT (datscan) and 123 I-ADAM dans la sclérose latérale amyotrophique et dans une population contrôle. DOSERALS
    A.3.2Name or abbreviated title of the trial where available
    DOSERALS
    A.4.1Sponsor's protocol code numberP080402
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 DaTSCAN
    D.2.1.1.2Name of the Marketing Authorisation holderGE Healthcare
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameDatscan
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNIoflupane 123I
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number74
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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.3.1Product name[I-123] ADAM
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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[I-123] ADAM
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30 +/- 10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 présentant une SLA et volontaires sains
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level PT
    E.1.2Classification code 10002026
    E.1.2Term Amyotrophic lateral sclerosis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Mettre en évidence une relation entre des modifications fonctionnelles des transporteurs de la sérotonine et de la dopamine et l'existence d'une rigidité pyramidale ou mixte (pyramidale et extra-pyramidale) dans la SLA.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients SLA :
    a) Patients masculin, féminin âgés de 39-66 ans, présentant une forme certaine, probable ou probable cliniquement de SLA dont l'évolution est comprise entre 3 mois et 5 ans, traités par riluzole depuis au moins 1 mois,
    b) sans rigidité (n=20), présentant une rigidité en rapport avec une atteinte pyramidale isolée (n=20) et présentant une rigidité mixte, pyramidale et extra-pyramidale (n=20),
    c) capables de comprendre les objectifs de l'étude , ayant signé le consentement (ou signé par une tierce personne en cas d'impossibilité physique conformément à l'article L1122-1-1)
    d) affiliés à un régime de sécurité sociale.

    Sujets contrôles :
    a) Sujets jugés sains par l'invesitgateur et présentant un examen physique normal
    b) Sujets masculin ou féminin âgés de 39 à 66 ans
    c) Sujets sans antécédent médical (neurologique/psychiatrique/addiction )
    d) Sujets sans traitement au long cours qui peuvent interférer avec les marqueurs excepté la contraception orale.
    e) Acceptant de participer à l'étude et ayant signé le consentement
    f) Affiliés à un régime de sécurité sociale.
    E.4Principal exclusion criteria
    Patient SLA :
    a) Existence d'une démence de type fronto-temporale
    b) Existence de, pathologies médicales évolutives interférant avec les évaluations,
    c) Existence de troubles psychiatriques majeurs.
    d) Prise médicamenteuse de psychotropes (anti-psychotiques, antidépresseurs, anxiolytiques) interférant avec le métabolisme de la sérotonine et/ou de la dopamine (ces différents traitements en cas d'inclusion devront être arrêtés depuis au moins 5 ½ vies avant l'entrée dans l'étude).
    e) Contre-indication à la réalisation d'une scintigraphie Dat-Scan/ADAM (allergie à la substance active ou à l'un des excipients, grossesse)
    f) Contre-indication à la réalisation d'une IRM (pacemaker clips vasculaires ferromagnétiques, corps étrangers ferromagnétiques intraoculaires, valves cardiaques anciennes, pompe à insuline, implants cochléaires, piercings, grossesse, claustrophobie)
    g) Antécédents de lésions cérébrales vasculaires, traumatiques ou tumorales rendant impossible la quantification des scintigraphies.
    h) Antécédents de cancer dans les 5 ans précédant l'étude, hormis les cancers cutanés type baso-cellulaire (non métastasés) ou les cancers in situ du col utérin
    i) Femmes enceintes, allaitantes, ou absence de contraception efficace chez les femmes en âge de procréer.
    j) Patients susceptibles de ne pas être co-opératif ou de se conformer aux exigences de l'essai (évalué par l'investigateur) ou ne pouvant être contacté en cas d'urgences

    Sujets contrôles :
    a) Ne présentant pas de contre-indications à la réalisation d'une IRM (pacemaker, clips vasculaires ferromagnétiques, corps étrangers ferromagnétiques intraoculaires, valves cardiaques anciennes, pompe à insuline, implants cochléaires, piercings, grossesse, claustrophobie)
    b) Ne présentant pas de contre-indications à la réalisation d'une scintigraphie Dat-Scan/ADAM (allergie à la substance active ou à l'un des excipients, grossesse)
    c) Femmes enceintes, allaitantes, ou absence de contraception efficace chez les femmes en âge de procréer.
    E.5 End points
    E.5.1Primary end point(s)
    Lors de l'inclusion
    pour les patients et contrôles :
    - critères démographiques, traitements concomitants
    - IRM cérébrale
    pour les patients SLA seulement :
    - Critères de diagnostic de SLA, date et lieu (bulbaire ou spinal) de début de la maladie, antécédents familiaux
    - Echelle ALS-FRS-R, évaluation de la raideur,
    - Echelles de depression MADRS, d'humeur dépressive et d'anxiété de Covi
    pour les patients SLA inclus à la Salpêtrière seulement : étude de l'initiation de la marche

    TEMP utilisant le 123 I-FP-CIT (DATSCAN) et 123I-ADAM réalisés à 1 semaine d'intervalle

    Les potentiels de liaison des transporteurs dopaminergiques et sérotoninergiques seront comparés à l'aide d'un modèle linéaire mixte.
    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 Yes
    E.6.13.1Other scope of the trial description
    Cognitif
    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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Etude prospective
    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 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 concerned2
    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 Information not present in EudraCT
    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
    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 months0
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    incapacité physique de signer le consentement. Dans ce cas le consentement sera signé par un proche
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    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 Decision2010-06-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-12
    P. End of Trial
    P.End of Trial StatusCompleted
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