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    Summary
    EudraCT Number:2017-004122-15
    Sponsor's Protocol Code Number:UF9889
    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:2018-06-04
    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 number2017-004122-15
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled trial comparing the efficacy and tolerance of sodium oxybate in patients affected with idiopathic hypersomnia.
    Etude bi-centrique contrôlée randomisée en double aveugle évaluant l'efficacité et la tolérance de l'oxybate de sodium chez les patients atteints d'hypersomnie idiopathique.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized, double-blind, placebo-controlled trial comparing the efficacy and tolerance of sodium oxybate in patients affected with idiopathic hypersomnia.
    A.3.2Name or abbreviated title of the trial where available
    SODHI
    SODHI
    A.4.1Sponsor's protocol code numberUF9889
    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 SponsorUniversity Hospital of Montpellier
    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 supportUniversity Hospital of Montpellier
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital of Montpellier
    B.5.2Functional name of contact pointTACONNET DECKER
    B.5.3 Address:
    B.5.3.1Street Address191, avenue du Doyen Gaston Giraud
    B.5.3.2Town/ cityMONTPELLIER
    B.5.3.3Post code34195
    B.5.3.4CountryFrance
    B.5.4Telephone number0033467335573
    B.5.5Fax number003346739172
    B.5.6E-mailg-taconnet_decker@chu-montpellier.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 Yes
    D.2.1.1.1Trade name XYREM Sodium Oxybate
    D.2.1.1.2Name of the Marketing Authorisation holderJAZZ Pharmaceuticals
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameSodium Oxybate
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation No
    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) 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 placeboOral solution
    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
    current idiopathic hypersomnia (ICSD-3)
    hypersomnie idiopathique
    E.1.1.1Medical condition in easily understood language
    idiopathic hypersomnia
    hypersomnie idiopathique
    E.1.1.2Therapeutic area Body processes [G] - Bones and nerves physological processes [G11]
    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
    Primary objective:
    To evaluate the efficacy of sodium oxybate on excessive daytime sleepiness using Epworth sleepiness scale over 8 weeks compared to placebo
    Evaluation de l'efficacité de l'oxybate de sodium chez des patients adultes atteints d’hypersomnie idiopathique en comparaison à un groupe placebo pour le traitement de la SDE évaluée à partir de l’échelle d’Epworth sur 8 semaines.
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of sodium oxybate on excessive daytime sleepiness using MWT latency over 8 weeks compared to placebo
    - To test the safety issue of sodium oxybate on excessive daytime sleepiness over 10 weeks.
    age that is applicable
    1) Evaluer l'efficacité de l'oxybate de sodium chez des patients adultes atteints d’hypersomnie idiopathique en comparaison à un groupe placebo pour le traitement de la SDE évaluée objectivement par le TME sur 8 semaines.
    2) Évaluer la tolérance sur 10 semaines de l'oxybate de sodium en comparaison à un groupe placebo pour le traitement de la SDE.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Diagnostic of idiopathic hypersomnia (ICSD-3 criteria)
    - Age between 18 and 60 years-old
    - BMI between 18 and 35 kg/m2
    - MSLT: mean sleep latency (MSL) of ≤8 minutes and < 2 SOREMPs
    - Polysomnography recording: sleep efficiency > 90%, total sleep time ≥6 hours, AHI <10/hour, micro-arousals index <15/hour, PLM index associated with micro-arousals <10/hour.
    - Absence of sleep deprivation, assessed by actigraphy or sleep logs
    - ESS score ≥14 points
    - Written informed consent
    - National health insurance cover
    1. Sujets ayant été informés, et ayant donné leur consentement
    2. Être capable de comprendre la nature, le but et la méthodologie de l'étude. Sujet ayant accepté la possibilité d’être traités par placebo durant la période de traitement.
    3. Être majeur et avoir < 60 ans
    4. Indice de masse corporelle (IMC) ≥18kg/m2 et ≤35kg/m2
    5. Diagnostic d’hypersomnie idiopathique selon les critères de l’ICSD-3
    6. Pour l’étude des critères d’inclusion supplémentaires (non présents dans l’ICSD-3) ont été rajoutés pour une évaluation plus précise de l’HI afin d’éliminer le plus possible d’autres conditions qui peuvent mimer l’HI.
    A. TILE réalisé dans l'année précédant l'étude montrant une latence d’endormissement ≤8 min et moins de deux endormissements en sommeil paradoxal (SOREMPs) (ou aucun si présence d’un SOREMP sur la PSG de la nuit).
    B. PSG réalisée dans l'année précédant l'étude satisfaisant les conditions suivantes :
    • Tous médicaments psychotropes sevrés au moins 15 jours avant la PSG
    • Efficacité du sommeil >90% et un temps total de sommeil (TTS) ≥6 heures
    • Absence d’une insuffisance de sommeil (TTS >7 heures par nuit lors des 15 jours avant l’étude, mesuré par l’actigraphie ou l’agenda de sommeil)
    • Index d’apnées-hypopnée (IAH) avec désaturation ≥3% à <10 / h
    • Index des micro-éveils à <15 / h
    • Index mouvements périodiques des membres (PLM) associés à des micro-éveils à <10 / h
    7. Score de l’ESS ≥14 points
    8. Toutes les femmes en âge de procréer devront utiliser une méthode de contraception fiable approuvée par l’investigateur ou accepter une abstinence sexuelle pendant l'étude et pendant les 30 jours après votre dernière dose de médicament à l'étude.
    9. Tous les hommes sexuellement actifs avec des partenaires de sexe féminin devront utiliser une méthode de contraception fiable approuvée par l’investigateur ou accepter une abstinence sexuelle pendant l'étude et pendant les 30 jours après votre dernière dose de médicament à l'étude.
    E.4Principal exclusion criteria
    - Current treatment with modafinil, amphetamine, methylphenidate, mazindol, pitolisant, neuroleptics, hypnotics, barbiturates, antidepressants*, anxiolytic drugs, anticonvulsive therapy, Valproate, budipine, dopamine antagonist antiemetics (except domperidone), opioids, benzodiazepines, Z-drugs, MAO inhibitors, COMT inhibitors, or sedative antihistamines. If patient has received such therapy, a washout-period of at least 15 days prior to the inclusion in the study is required before starting treatment in this study.
    *30 days for antidepressants
    - Succinic semialdehyde dehydrogenase deficiency
    - Other central nervous system diseases: neurodegenerative diseases, seizure disorders or history of head trauma associated with loss of consciousness
    - Lifetime history of suicide attempt or suicidal ideation in the past 6 months, prior history of psychotic episodes, Beck depression inventory (BDI) > 16 and/or item G> 0
    - History of chronic alcohol or drug abuse within the prior 12 months
    - Malignant neoplastic disease requiring therapy within 12 months prior to Visit 1 or clinically relevant
    - cardiovascular disease compromising the patient’s wellbeing or ability to participate in this study
    - chronic renal insufficiency
    - No regular sleep at night: shift work or other continuous non–disease-related life conditions
    - Participation in another study of an investigational drug within the 28 days prior to Visit 1 or currently
    - Hypersensitivity to any of the components of the study medication
    - Pregnancy (βHCG positive) and breast-feeding
    1. Prise de certains médicaments si non sevrés au moins 15 jours avant l’inclusion dans l’étude. Les traitements concernés sont les suivants : modafinil, amphétamine, méthylphénidate, mazindol, pitolisant, neuroleptiques, barbiturates, hypnotiques, antidépresseurs*, anxiolytiques, antiépileptiques, valproate, budipine, antiémétiques antagonistes de la dopamine (sauf dompéridone), opiacés, benzodiazépines, hypnotiques Z (zolpidem et zopiclone), inhibiteurs de la monoamine oxydase (IMAO), catéchol-O-méthyltransférase (COMT) ou antihistaminiques sédatifs.
    *Compte tenu de la demi-vie longue de certains antidépresseurs, un sevrage de 30 jours sera nécessaire pour les patients traités par ceux-ci.
    2. Autres maladies du système nerveux central : maladie de Parkinson, démence, paralysie supranucléaire progressive, atrophie multisystématisée, choréa de Huntington, sclérose latérale amyotrophique, maladie d'Alzheimer, épilepsie, antécédent de traumatisme crânien avec perte de connaissance
    3. Antécédents de tentative de suicide (y compris une tentative avortée), ou des idées suicidaires au cours des 6 derniers mois
    4. Antécédents d'épisodes psychotiques (schizophrénie, paranoïa, manie)
    5. Patient ayant une insuffisance en semi-aldehyde succinique dehydrogenase

    6. Consommation chronique d'alcool ou abus de drogues dans les 12 mois précédents
    7. Maladie médicales ou psychiatriques pouvant interférer avec le déroulement de l’étude
    8. Inventaire de dépression de Beck (BDI) avec un score >16 et/ou avec l’item G >0
    9. Sujet présentant une maladie néoplasique maligne ayant nécessité un traitement thérapeutique dans les douze mois précédant la visite de screening
    10. Sujet avec maladies cardiovasculaires cliniquement significatives qui, selon l’opinion de l’investigateur, peuvent compromettre l’état de santé du sujet ou sa capacité de participer à l’étude
    11. Insuffisance rénale chronique
    12. Travail posté ou sujet avec des rythmes veille-sommeil irréguliers
    13. Sujet participant ou ayant participé dans les 28 jours avant la Visite 1 à une autre étude portant sur un médicament expérimental
    14. Hypersensibilité connue à une ou plusieurs des composantes du traitement à l’étude
    15. Femmes enceintes ou qui ont la possibilité d’être enceinte
    16. Femmes allaitantes
    17. personnes privées de liberté par une décision judiciaire ou administrative
    18. Les personnes majeures faisant l'objet d'une mesure de protection légale ou hors d'état d'exprimer leur consentement
    19. Sujets qui ne sont pas dans les moyennes de tolérer les contraintes liées à l’étude
    20. Patients n’étant pas affiliés à un régime de sécurité sociale.
    E.5 End points
    E.5.1Primary end point(s)
    ESS score at the end-point visit
    Score de l’ESS à 8 semaines (Echelle de Somnolence d’Epworth)
    E.5.1.1Timepoint(s) of evaluation of this end point
    8 weeks
    8 semaines
    E.5.2Secondary end point(s)
    - No residual sleepiness (ESS < 11) and good responders (decreased ESS >3 points) at 8-weeks
    - Mean sleep latency (minutes) on MWT at 8-weeks
    - % sleep stages, total sleep time (min), sleep efficiency, microarousal index on polysomnography assessment at 8-weeks
    - Duration of nighttime sleep (min) at 8-weeks
    - Clinical global impression change and severity on sleepiness at 8 weeks ( CGI-C and CGI-S)
    - Life quality and health state at 8-weeks (EQ-5D)
    - Intensity and duration of sleep inertia (assessed on a visual analog scale from 0 to 10)
    - Questionnaire on Hyper somnolence severity
    E.5.2.1Timepoint(s) of evaluation of this end point
    8 semaines
    8 semaines
    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 No
    E.6.4Safety Yes
    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) 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 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.8.2.4Number 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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: 24
    F.1.3Elderly (>=65 years) No
    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 state24
    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 Decision2018-03-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-04-12
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