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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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:2014-000848-14
    Sponsor's Protocol Code Number:38RC12.228
    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:2015-06-17
    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 number2014-000848-14
    A.3Full title of the trial
    Endothelin and Ischemic optic Neuropathy study group
    Evaluation des effets du bosentan dans la prise en charge des patients à la phase aiguë de la neuropathie optique ischémique antérieure aiguë
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Endothelin and Ischemic Optic Neuropathy study group
    ENDOTHELION
    A.3.2Name or abbreviated title of the trial where available
    Endothelin and Ischemic Optic Neuropathy study group
    ENDOTHELION
    A.4.1Sponsor's protocol code number38RC12.228
    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 SponsorCentre Hospitalier Universitaire de Grenoble
    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 supportDGOS Ministère de la santé
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDRCI
    B.5.2Functional name of contact pointDirecteur
    B.5.3 Address:
    B.5.3.1Street AddressPavillon saint Eynard CS 10217
    B.5.3.2Town/ cityGRENOBLE
    B.5.3.3Post code38043 GRENOBLE
    B.5.3.4CountryFrance
    B.5.4Telephone number330476768455
    B.5.5Fax number330476765221
    B.5.6E-mailMCoutard@chu-grenoble.fr
    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.2.1.2Country 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.3.1Product namebosentan Pharmascience
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPBuccal 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
    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 placeboBuccal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Endothelin and Ischemic Optic Neuropathy study group
    neurophatie optique ischémique antérieur aiguë
    E.1.1.1Medical condition in easily understood language
    Ischemic Optic Neuropathy
    neuroptahie ischémique
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Compare the evolution of the field of vision 3 months after the beginning of the NOIAA as they receive either from the bosentan to the posology of 250 mg a day, or the placebo during a duration of 8 weeks.
    Comparer l’évolution du champ visuel 3 mois après le début de la NOIAA selon qu’ils reçoivent soit du bosentan à la posologie de 250 mg par jour, soit le placebo pendant une durée de 8 semaines.
    E.2.2Secondary objectives of the trial
    Compare the thickness of péripapillaires optical fibers at patients reached(affected) by NOIAA 3, 6, 12 and 24 months after the beginning of the NOIAA as they receive either from the bosentan to the posology of 250 mg a day, or the placebo during 8 weeks.
    Compare the visual function(office) (visual acuteness and field of vision) in 6, 12 and 24 months as they receive either from the bosentan to the posology of 250 mg a day, or the treatment(processing) placebo.
    Markers(Scorers) of the inflammation and dosage plasmatique of the prépro-endothéline in 3 months
    Function(Office) endothéliale measured in the peripheral arterial tonus (PAT, 3 centers: CHU(TEACHING HOSPITAL) of Grenoble, Angers and Saint-Etienne only) in 3 months
    Rate of bilatéralisation of the NOIAA in 24 months
    Evaluation of the field of vision of the eye controlatéral it périmétrie automated
    Comparer l’épaisseur des fibres optiques péripapillaires chez des patients atteints de NOIAA 3, 6, 12 et 24 mois après le début de la NOIAA selon qu’ils reçoivent soit du bosentan à la posologie de 250 mg par jour, soit le placebo pendant 8 semaines.
    Comparer la fonction visuelle (acuité visuelle et champ visuel) à 6, 12 et 24 mois selon qu’ils reçoivent soit du bosentan à la posologie de 250 mg par jour, soit le traitement placebo.
    Marqueurs de l’inflammation et dosage plasmatique de la prépro-endothéline à 3 mois
    Fonction endothéliale mesurée au tonus artériel périphérique (PAT, 3 centres : CHU de Grenoble, Angers et Saint-Etienne uniquement) à 3 mois
    Taux de bilatéralisation de la NOIAA à 24 mois
    Evaluation du champ visuel de l’œil controlatéral en périmétrie automatisée (Humphrey 30-2 sita-standard)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Men(People) or women of more than 50 years,
    Negative pregnancy test and use of an effective not hormonal contraception during all the duration of the study for the not menopausal women OR(WHERE) the menopause
    Patients having signed the form of consent,
    Patients affiliated to a national insurance scheme or a beneficiary of such a diet(regime).

    The diagnosis of NOIAA is put in front of the recent appearance (lower in 21 days) a change of the field of vision, associated or not with a reduction in quickly progressive or rough painless visual acuteness and/or
    AND associated with the clinical examination in an oedema papillaire diffuse or sectorial, of pale / white color, sometimes with péripapillaires bleedings.
    The diagnosis of disease of Horton must be eliminated (cf page 22)
    The diagnosis of a syndrome of apnea of the obstructive sleep (index of apneas-hypopnées = the 15 / hour of recording) is not essential for the randomization. Given that the not expanding(carrier) patients of a SAS(AIRLOCK,SIEVE) represent 15 % of the population studied NOIAA, an analysis a posteriori of these patients will be realized.
    Hommes ou femmes de plus de 50 ans,
    Test de grossesse négatif et utilisation d’une contraception non hormonale efficace pendant toute la durée de l’étude pour les femmes non ménopausées OU ménopause
    Patients ayant signé le formulaire de consentement,
    Patients affiliés à un régime de sécurité sociale ou bénéficiaire d’un tel régime.

    Le diagnostic de NOIAA est posé devant l’apparition récente (inférieure à 21 jours)
    une altération du champ visuel,
    associée ou pas à une baisse d’acuité visuelle indolore rapidement progressive ou brutale et/ou
    ET associée à l’examen clinique à un œdème papillaire diffus ou sectoriel, de couleur pâle/blanc, parfois avec des hémorragies péripapillaires.
    Le diagnostic de maladie de Horton devra être éliminé (cf page 22)

    Le diagnostic d’un syndrome d’apnées-hypopnées du sommeil obstructif (index d’apnées-hypopnées ≥ 15/heure d’enregistrement) n’est pas indispensable pour la randomisation. Etant donné que les patients non porteurs d’un SAS représentent 15% de la population NOIAA étudiée, une analyse a posteriori de ces patients sera réalisée.
    E.4Principal exclusion criteria
    Cannot be included the subjects answering in at least one of the following criteria:
    Pregnant woman, parturiente or nursing mother
    Women old enough to procreate using a hormonal alone contraception, about is its mode of administration.
    Signs which can make suspect another inflammatory neuropathy: NOIAA artéritique (disease of Horton), pain during the mobilization of the globe or any sign which can evoke an optical névrite, a diagnosis known for SEP(MULTIPLE SCLEROSIS), history of inflammatory optical neuropathy (gay or ipsi-side). A biopsy of the temporal artery will be realized if symptoms evoking Horton, or pale and/or diffuse oedema, or franking(obliteration) of the central artery of the associated retina.
    Signs which can evoke a retinal pathology,
    Signs which can evoke a neuroretinitis or another optical neuropathy. Any atypie will require the realization of a brain imaging (MRI)

    Patients reached(affected) by another eye pathology intercurrente acute(sharp) or chronic interfering on the visual acuteness or the field of vision (rétinopathie diabetic, medicinal or other, other optical neuropathy pressure of which close(plain) glaucoma or controlatéral and/or intraoculaire > 30 mmHg, cataract(waterfall) advance(overhang), corneal opacities, amblyopia 5/10, strong nearsightedness > 6 dioptres)
    Simultaneous bilateral NOIAA, spaced out of 1 month or less
    Ne pourront pas être inclus les sujets répondant à au moins un des critères suivants :
    Femme enceinte, parturiente ou mère qui allaite
    Femmes en âge de procréer utilisant une contraception hormonale seule, quelque soit son mode d’administration.

    Patients atteints d’une autre pathologie oculaire intercurrente aiguë ou chronique interférant sur l’acuité visuelle ou le champ visuel (rétinopathie diabétique, médicamenteuse ou autre, autre neuropathie optique dont glaucome uni ou controlatéral et/ou pression intraoculaire > 30 mmHg, cataracte avancée, opacités cornéennes, amblyopie < 5/10, myopie forte > -6 dioptries)
    NOIAA bilatérale simultanée, espacée de 1 mois ou moins
    Signes pouvant faire suspecter une autre neuropathie inflammatoire : NOIAA artéritique (maladie de Horton), douleur lors de la mobilisation du globe ou tout signe pouvant évoquer une névrite optique, diagnostic connu de SEP, antécédent de neuropathie optique inflammatoire (homo ou ipsi-latéral). Une biopsie de l’artère temporale sera réalisée si symptômes évoquant un Horton, ou œdème pâle et/ou diffus, ou oblitération de l‘artère centrale de la rétine associée.
    Signes pouvant évoquer une pathologie rétinienne,
    Signes pouvant évoquer une neurorétinite ou une autre neuropathie optique. Toute atypie nécessitera la réalisation d’une imagerie cérébrale (IRM)
    E.5 End points
    E.5.1Primary end point(s)
    Automated field of vision (Humphrey 30-2 sita-standard)
    champ visuel automatisé (Humphrey 30-2 sita-standard)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Field of vision automated (detour(deviation) averages in the test Humphrey 30-2 and 60-4 sita-standard, dB) for the healthy eye and the eye NOIAA
    Retinal thickness of nerve fibers (in micrometer) measured in central visual SD-OCT acuteness (scale(ladder) ETDRS)
    Biomarkers of the inflammation: RANTES, MCP-1, TNF-? INF-? IL-6, IL-10 and TGF-? Dosage plasmatique of the prépro-endothéline
    Function(Office) endothéliale by measure of the peripheral arterial tonus (PAT)
    Rate of bilatéralisation of the controlatéral eye (arisen a NOIAA) in 24 months
    champ visuel automatisé (déviation moyenne au test Humphrey 30-2 et 60-4 sita-standard, en dB) pour l’œil sain et l’œil NOIAA
    épaisseur des fibres nerveuses rétinienne (en micromètre) mesurée en SD-OCT
    acuité visuelle centrale (échelle ETDRS)
    Biomarqueurs de l’inflammation: RANTES, MCP-1, TNF-, INF-γ, IL-6, IL-10 et TGF-
    dosage plasmatique de la prépro-endothéline
    Fonction endothéliale par mesure du tonus artériel périphérique (PAT)
    Taux de bilatéralisation de l’œil controlatéral (survenue d’une NOIAA) à 24 mois
    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 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 No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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.8.2.4Number 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 concerned6
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA6
    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
    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 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: 43
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 43
    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 state12
    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
    non
    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 Decision2014-07-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-24
    P. End of Trial
    P.End of Trial StatusOngoing
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