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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   42564   clinical trials with a EudraCT protocol, of which   7007   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).

    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2018-000503-16
    Sponsor's Protocol Code Number:P170903J
    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:2020-06-08
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2018-000503-16
    A.3Full title of the trial
    Randomized, double-blind, single-centre, randomized study evaluating the efficacy of CLORazepate dipotassium in the treatment of migraine crisis in the emergency department.
    Étude monocentrique randomisée en double aveugle évaluant l’efficacité du CLORazépate dipotassique dans le traitement de la crise de MIGraine aux urgences
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the efficacy of dipotassium clorazepate in the treatment of migraine in the emergency department
    Etude de l'efficacité du clorazépate dipotassique dans le traitement de la migraine aux urgences
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberP170903J
    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 SponsorAssistance Publique- Hôpiaux de Paris
    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
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAssistance Publique - Hôpitaux de Paris
    B.5.2Functional name of contact pointLaura Blanchet/ Karine SEYMOUR
    B.5.3 Address:
    B.5.3.1Street AddressHôpital Saint-Louis, DRCI, 1, av. Claude Vellefaux
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75010
    B.5.4Telephone number0033144841742
    B.5.5Fax number033144841701
    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. name Tranxène
    D. of the Marketing Authorisation holderSanofi - Aventis
    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 nameTranxene
    D.3.4Pharmaceutical form Lyophilisate and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPParenteral use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNClorazepate dipotassique
    D.3.9.3Other descriptive nameCHLORAZEPATE
    D.3.9.4EV Substance CodeSUB32039
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 Yes
    D. medicinal product typeNaCl 0,9% 100mL
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboParenteral use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Adults of full age, excluding pregnant or breastfeeding women, admitted to the CUC for headaches
    Adultes majeurs à l’exclusion des femmes enceintes ou allaitantes, admis au CUC pour céphalée
    E.1.1.1Medical condition in easily understood language
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    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
    To evaluate the value of CDP IV as an add-on to the standard treatment of migraine attacks (ketoprofen +/- metoclopramide) compared to placebo for the relief of migraine headache in the emergency department.
    Évaluer l’intérêt du CDP IV en « add-on » du traitement classique de la crise de migraine (kétoprofène +/- métoclopramide) comparativement au placebo pour soulager la céphalée migraineuse aux urgences
    E.2.2Secondary objectives of the trial
    - Evaluate the efficacy of CDP IV compared to placebo
    o on complete headache relief
    o on the recurrence of headache at 24 hours
    o on the need for rescue treatment
    o on the intensity of acute anxiety at 2 and 24 hours after administration
    o on the signs associated with headaches (nausea/vomiting, photophobia, phonophobia)
    o on the frequency and intensity of metoclopramide-induced akathisia within 2 hours of administration.
    o on the memory of the stay in the emergency room
    o on the impact of the crisis
    o on overall patient satisfaction
    - Assess CDP tolerance (drowsiness)

    Translated with www.DeepL.com/Translator (free version)
    • Évaluer l’efficacité du CDP IV comparativement au placebo
    o sur le soulagement complet de la céphalée
    o sur la récurrence de la céphalée à 24h
    o sur la nécessité de recourir à un traitement de secours
    o sur l’intensité de l’anxiété aiguë à 2 et 24 heures après administration
    o sur les signes associés aux céphalées (nausées/vomissements, photophobie, phonophobie)
    o sur la fréquence et l’intensité de l’akathisie induite par le métoclopramide dans les 2h de son administration
    o sur le souvenir du séjour aux urgences
    o sur le retentissement de la crise
    o sur la satisfaction globale du patient
    • Évaluer la tolérance du CDP (somnolence)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient 18 to 70 years old
    - Patient with a migraine or probable migraine, with or without aura, episodic or chronic, meeting the IHCD3 (International Classification of Headache Disorders 3rd edition) criteria, the diagnosis being made by a neurologist.
    - Crisis of a duration ≤ 72h
    - Intensity of moderate or severe headache on the ordinal verbal pain scale
    - Patient affiliated to a social security scheme

    Translated with www.DeepL.com/Translator (free version)
    • Patient de 18 à 70 ans
    • Patient présentant une migraine ou une migraine probable, avec ou sans aura, épisodique ou chronique, répondant aux critères IHCD3 (International Classification of Headache Disorders 3rd edition), le diagnostic étant posé par un neurologue
    • Crise d’une durée ≤ 72h
    • Intensité de la céphalée modérée ou sévère sur l’échelle verbale ordinale de la douleur
    • Patient affilié à un régime de sécurité sociale
    E.4Principal exclusion criteria
    - Abnormalities of neurological examination, coma attack and/or fever (temperature ≥ 38°C), PAS≥180 and/or PAD≥110 mmHg
    - Suspicion of secondary headache
    - Inability to understand informed consent or questionnaires
    - Pregnancy and breastfeeding
    - Known respiratory insufficiency and/or sleep apnea
    - Known liver failure
    - Acute or chronic alcohol poisoning
    - Myasthenia gravis
    - Recent use of benzodiazepines
    o < 24h for long-acting benzodiazepines (diazepam, clonazepam, CDP)
    o < 6 hours for shorter acting benzodiazepines (alprazolam, lorazepam, midazolam)
    - Taking recent analgesics (<2h)
    - Allergy, or known hypersensitivity and/or other contraindications to CDP, another benzodiazepine, ketoprofen and/or metoclopramide
    - Contraindication to the use of an intravenous approach
    - Patient who has already participated in this study
    - Patient participating in other research involving the human person

    • Anomalies de l’examen neurologique, crise comitiale et/ou fièvre (température ≥ 38°C), PAS≥180 et/ou PAD≥110 mmHg
    • Suspicion de céphalée secondaire
    • Incapacité à comprendre le consentement éclairé ou les questionnaires
    • Grossesse-allaitement
    • Insuffisance respiratoire et/ou apnées du sommeil connues
    • Insuffisance hépatique connue
    • Intoxication alcoolique aiguëe ou chronique
    • Myasthénie
    • Utilisation récente de benzodiazépines
    o < 24h pour les benzodiazépines à longue durée d’action (diazepam, clonazepam, CDP)
    o < 6h pour les benzodiazépines à durée d’action moins longue (alprazolam, lorazepam, midazolam)
    • Prise d’antalgiques récentes (<2h)
    • Allergie, ou hypersensibilité connue et/ou autre contre-indication au CDP, à une autre benzodiazépine, au kétoprofène et/ou au métoclopramide
    • Contre-indication à l’utilisation d’un abord intraveineux
    • Patient ayant déjà participé à cette étude
    • Patient participant à une autre recherche impliquant la personne humaine

    • Utilisation récente de benzodiazépines
    o < 24h pour les benzodiazépines à longue durée d’action (diazepam, clonazepam, CDP)
    o < 6h pour les benzodiazépines à durée d’action moins longue (alprazolam, lorazepam, midazolam)
    • Prise d’antalgiques récentes (<2h)
    • Allergie, ou hypersensibilité connue et/ou autre contre-indication au CDP, à une autre benzodiazépine, au kétoprofène et/ou au métoclopramide
    • Contre-indication à l’utilisation d’un abord intraveineux
    • Patient ayant déjà participé à cette étude
    • Patient participant à une autre recherche impliquant la personne humaine
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients reporting partial or complete relief at 2 hours ("pain relief"): change from severe or moderate intensity to mild or absent on the EVO (Ordinal Verbal Pain Scale), 4-level scale: severe-moderate-light-absent.
    Pourcentage de patients rapportant un soulagement partiel ou complet à 2 heures (« pain relief ») : passage d’une intensité sévère ou modérée à légère ou absente à l’EVO (Échelle Verbale Ordinale de la douleur), échelle à 4 niveaux : sévère-modérée-légère-absente.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 hours
    2 heures
    E.5.2Secondary end point(s)
    Percentage of patients reporting total relief at 2 hours ("pain free"): change from severe or moderate intensity to mild or no EVO
    - Percentage of patients with sustained pain free: complete relief at 2 hours (EVO) with no recurrence of moderate or severe headache and no pain medication at 24 hours.
    - Change in headache intensity from T0 (IV administration) to T+2h and T+24h, as assessed by the Analogue Verbal Pain Scale 0-10 (AVS).
    - Percentage of patients reporting total relief within 2 hours of their most troublesome migraine symptom among nausea, photophobia and phonophobia
    - Percentage of Patients Requiring Additional Crisis Treatment in the Emergency Department (Salvage Treatment)
    - Variation in the intensity of acute anxiety at 2 hours and 24 hours: Visual Anxiety Analog Scale (VASnx)
    - Akathisia scale (no agitation, slightly agitated, clearly agitated) at 2 hours
    - Sleepiness Score: 3-level ordinal scale (not drowsy, slightly drowsy but able to function normally or too drowsy to function normally) at 2:00 a.m. and question: "Have you slept since the treatments were administered? "at 2:00 a.m.
    - Transient anterograde amnesia scale: verbal analogue scale between 0 and 10 at 24 hours
    - Impact Scale: 4-level ordinal scale: absent, mild, moderate, severe
    - Composite overall satisfaction scores :
    o Patient global impression of change (PGIC) scale between 1 and 7, from 1 = significant improvement to 7 = significant worsening at 2hrs.
    o Dichotomous criterion "would you like to receive the same treatment the next time you go to the emergency room" at 24 hrs.
    • Pourcentage de patients rapportant un soulagement total à 2 heures (« pain free ») : passage d’une intensité sévère ou modérée à légère ou absente à l’EVO
    • Pourcentage de patients avec soulagement complet maintenu (« sustained pain free ») : soulagement complet à 2h (EVO) sans récidive de céphalée modérée ou sévère et sans prise d’antalgique à 24h
    • Variation de l’intensité de la céphalée de T0 (administration IV) à T+2h et T+24h, évaluée par Échelle Verbale Analogique de la douleur de 0 à 10 (EVA)
    • Pourcentage de patients rapportant un soulagement total à 2 heures de leur symptôme migraineux le plus gênant parmi nausées, photophobie et phonophobie
    • Pourcentage de patients ayant besoin d’un traitement de crise supplémentaire aux urgences (traitement de secours)
    • Variation de l’intensité d’anxiété aiguëe à 2h et 24h : Échelle Visuelle analogique d’Anxiété (EVAnx)
    • Échelle d’akathisie (pas d’agitation, légèrement agité, nettement agité) à 2h
    • Score de somnolence : échelle ordinale à 3 niveaux (pas somnolent, légèrement somnolent mais capable de fonctionner normalement ou trop somnolent pour fonctionner normalement) à 2h et question : « Avez-vous dormi depuis l’administration des traitements? » à 2h
    • Échelle d’amnésie antérograde transitoire : échelle verbale analogique entre 0 et 10 à 24h
    • Échelle de retentissement : échelle ordinale à 4 niveaux : absent, léger, modéré, sévère
    • Score composites de satisfaction globale :
    o Patient global impression of change (PGIC) échelle entre 1 et 7, de 1 = nette amélioration à 7 = nette aggravation à 2h
    o Critère dichotomique « voudriez-vous recevoir le même traitement lors d’un prochain passage aux urgences » à 24h
    E.5.2.1Timepoint(s) of evaluation of this end point
    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. 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) Yes
    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 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 Yes
    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
    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: 420
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 420
    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 state420
    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)
    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 Decision2020-07-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-12
    P. End of Trial
    P.End of Trial StatusOngoing
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