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    The EU Clinical Trials Register currently displays   44237   clinical trials with a EudraCT protocol, of which   7338   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).

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    Summary
    EudraCT Number:2007-004922-26
    Sponsor's Protocol Code Number:0720101
    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:2008-01-31
    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 number2007-004922-26
    A.3Full title of the trial
    Evaluation de l’effet de la fluoxétine chez le patient atteint d’atrophie multi-systématisée : Etude randomisée en double-insu versus placebo.
    A.3.2Name or abbreviated title of the trial where available
    Etude MSA-fluoxétine
    A.4.1Sponsor's protocol code number0720101
    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 SponsorCHU Toulouse
    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 PROZAC
    D.2.1.1.2Name of the Marketing Authorisation holderLilly France
    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 Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral 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) 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 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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule*
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    atrophie multisystématisée
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10064060
    E.1.2Term Multiple system atrophy
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluer l’effet de la fluoxétine à la dose de 40 mg/jour après 3 mois de traitement sur les symptômes de la MSA évalués à l’aide des parties I et II de l’échelle UMSARS.
    E.2.2Secondary objectives of the trial
    Les objectifs secondaires d’évaluer les effets de la fluoxétine à 20 mg/j sur les symptômes de la MSA évalués à l’aide des parties I et II de l’échelle UMSARS et les effets de 2 doses de fluoxétine (20 et 40 mg/j) sur la mortalité, les troubles végétatifs et en particulier l’hypotension orthostatique, l’humeur et la qualité de vie des malades.
    Les objectifs exploratoires de ce protocole sont de décrire et d’évaluer les effets de la fluoxétine sur des signes non moteurs mal connus dans cette pathologie comme les troubles du sommeil, l’apathie, la douleur et la fatigue. Parallèlement cette étude permettra aussi d’évaluer l’effet placebo dans cette population de malades.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - MSA probable diagnostiquée, selon les critères consensuels internationaux
    - Age de 30 à 80 ans encore capable de se déplacer à certains moments de la journée sans l’aide d’un fauteuil roulant
    - Absence de troubles cognitifs susceptibles de compromettre la qualité de compréhension et de participation du malade au protocole et aux critères de jugement (carnets de bord inclus)
    - Malade recevant un traitement antiparkinsonien stable depuis au moins 2 mois et chez qui l’on présume qu’il sera possible de maintenir ce traitement inchangé pendant la durée de l’étude
    - Malade recevant un traitement symptomatique des troubles végétatifs stable depuis au moins 2 mois et chez qui l’on présume qu’il sera possible de maintenir ce traitement inchangé pendant la durée de l’étude
    - Malade ayant donné son consentement libre et éclairé et signé le consentement
    - Etant affilié à un régime de sécurité sociale.
    E.4Principal exclusion criteria
    - Patient recevant déjà un IRSS ou en ayant reçu un dans les 3 mois précédents le début de l’étude
    - Patients présentant un syndrome dépressif majeur, chez lequel l’investigateur considère que l’indication d’un antidépresseur semble indispensable
    - Patient grabataire ou confiné au fauteuil roulant durant l’ensemble de la journée
    - Patient présentant une hyponatrémie sévère
    - Patient présentant un autre syndrome parkinsonien que la MSA (de type Maladie de Parkinson Idiopathique, Paralysie Supra Nuclaire Progressive, Dégénrescence Cortico Basale,etc...)
    - Patient atteint d’une démence,
    - Patient incapable de comprendre le protocole ou un autre critère de jugement ou de suivre les procédures de l’essai clinique.
    - Patient atteint d’une maladie chronique compromettant l’évolution ou l’évaluation du malade durant la durée de l’essai
    - Patient recevant des traitements concomitants risquant de perturber l’évaluation des critères de jugement (par exemple neuroleptiques pour l’évaluation des symptômes parkinsoniens, vasodilatateurs pour l’évaluation de l’hypotension orthostatique, médicaments sédatifs prescrits durant la journée pour l’évaluation de la somnolence diurne, de l’apathie ou de l’asthénie).
    - Contre-indications absolues ou relatives à la fluoxétine : hypersensibilité connue à la fluoxétine, patient présentant des antécédents d’épilepsie, d’état maniaque, d’insuffisance hépatique ou rénale sévère, d’hémorragie cutanée, de cardiopathie sévère, de diabète mal équilibré, patient traité par IMAO sélectif s ou non sélectifs.
    - Femme enceinte ou susceptible de l’être, allaitement.
    E.5 End points
    E.5.1Primary end point(s)
    Le critère principal, variable quantitative, est la différence, entre les temps 0 et 3 mois, des valeurs de la somme de scores UMSARS I et II.
    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) 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 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.8.3 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 concerned16
    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
    Dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 Information not present in EudraCT
    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 state88
    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)
    cf protocol
    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 Decision2008-02-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-11
    P. End of Trial
    P.End of Trial StatusOngoing
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