Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   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 on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-002849-42
    Sponsor's Protocol Code Number:RC-P0103
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-02-22
    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 number2020-002849-42
    A.3Full title of the trial
    GRADE : EFFICACITE A COURT TERME DE LA GABAPENTINE VERSUS PLACEBO DANS LES RADICULALGIES LOMBOSACREES (RLS) AIGUES PAR HERNIE DISCALE : ETUDE PROSPECTIVE, MULTICENTRIQUE, RANDOMISEE, CONTROLEE, EN DOUBLE AVEUGLE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    GRADE : EFFICACITE A COURT TERME DE LA GABAPENTINE VERSUS PLACEBO DANS LES RADICULALGIES LOMBOSACREES (RLS) AIGUES PAR HERNIE DISCALE
    A.3.2Name or abbreviated title of the trial where available
    GRADE
    A.4.1Sponsor's protocol code numberRC-P0103
    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 SponsorGROUPEMENT DES HOPITAUX DE L'INSTITUT CATHOLIQUE DE LILLE
    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 supportHealth ministry (Direction Générale de l'Offre de Soins - DGOS)
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGROUPEMENT DES HOPITAUX DE L'INSTITUT CATHOLIQUE DE LILLE
    B.5.2Functional name of contact pointClinical trial associate
    B.5.3 Address:
    B.5.3.1Street Address115 rue du grand but
    B.5.3.2Town/ cityLOMME
    B.5.3.3Post code59462
    B.5.3.4CountryFrance
    B.5.4Telephone number+33320225269
    B.5.5Fax number+33320225767
    B.5.6E-mailURM@ghicl.net
    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 GABAPENTINE
    D.2.1.1.2Name of the Marketing Authorisation holderBIOGARAN
    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 nameGABAPENTINE
    D.3.4Pharmaceutical form Capsule
    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 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
    Radiculalgies LomboSacrées
    E.1.1.1Medical condition in easily understood language
    La Radiculalgie LomboSacrée, plus communément appelée « sciatique » est une pathologie fréquente due le plus souvent à la compression d’un nerf au niveau du dos, causant des douleurs dans la jambe.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10081091
    E.1.2Term Lumbar radicular pain
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10076578
    E.1.2Term Lumbosacral radiculopathy
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10066256
    E.1.2Term Lumbar disc herniation
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluer l’efficacité antalgique de la Gabapentine versus Placebo à court terme (72h) dans les RLS aigues par hernie discale.
    E.2.2Secondary objectives of the trial
    1.Evaluer la tolérance de la Gabapentine vs Placebo
    2.Evaluer l’efficacité antalgique à court terme de la Gabapentine vs Placebo sur la composante lombalgique
    3.Evaluer l’efficacité antalgique de la Gabapentine vs Placebo sur les composantes radiculalgie et lombalgie à J7
    4.Comparer les caractéristiques cliniques neuropathiques des RLS aigues sous traitement et dans les jours suivant l’arrêt du traitement
    5.Evaluer le lien entre l’efficacité antalgique de la Gabapentine vs Placebo et la présence initiale de caractéristiques cliniques plaidant pour l’existence de douleurs neuropathiques
    6.Evaluer la capacité de la Gabapentine vs Placebo à réduire le recours aux interdoses d’antalgique anti-nociceptif
    7.Evaluer la capacité de la Gabapentine vs Placebo à réduire le traitement antalgique anti-nociceptif associé à J7
    8.Si la répartition le permet dans le groupe Gabapentine, évaluer l’influence de la consommation d’antidépresseurs et antiépileptiques sur la réponse au traitement
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Age ≥ 18 ans,
    -Radiculalgie ou lomboradiculalgie de moins de 3 mois (douleur d’un membre inférieur systématisée à un territoire radiculaire, éventuellement associée à une douleur lombaire),
    -Prise en charge en hospitalisation pour une durée minimale de 72 heures après inclusion,
    -Radiculalgie initiale EVA ≥ 4 (douleur modérée à intense),
    -Hernie discale concordante entre la symptomatologie clinique et l’imagerie (scanner ou IRM) datant de moins de 3 mois,
    -Consentement écrit signé du patient,
    -Affiliation à un régime de sécurité sociale
    E.4Principal exclusion criteria
    -Déficit neurologique moteur (≤ 3/5) ou syndrome de la queue de cheval (indications chirurgicales en urgence),
    -Antécédent de chirurgie lombaire,
    -Antécédent de douleur neuropathique préexistante dans le membre inférieur concerné par la radiculalgie,
    -Infiltration lombaire dans les 72 heures précédant l’inclusion,
    -Infiltration lombaire réalisée dans les 72 heures précédant l’inclusion ou ne pouvant être réalisée au-delà d’un délai de 72h
    -Patient déjà sous Gabapentine ou sous Prégabaline, ou ayant pris ces traitements dans les 7 jours précédant l’inclusion
    -Contre-indication à la Gabapentine (Hypersensibilité à la substance active ou à l'un des excipients : amidon de maïs, talc, oxyde de fer jaune, dioxyde de titane, laurylsulfate de sodium, gélatine, gomme laque, du propylène glycol, de l'oxyde de fer noir et de l'hydroxyde de potassium)
    -Clairance de la créatinine < 30ml/min,
    -Patient hémodialysé,
    -Poids corporel < 50kgs,
    -Patient transplanté
    -Patient sous tutelle ou curatelle
    -Femme enceinte ou allaitante
    E.5 End points
    E.5.1Primary end point(s)
    Evolution de l’Échelle Visuelle Analogique (EVA) radiculalgie entre H0 et H72, H0 correspondant à la 1ère dose administrée du traitement (Gabapentine ou Placebo).
    De manière annexe, le taux de répondeurs à H72 (= EVA douleur radiculalgie < 40/100) sera également calculé, mais seule l’évolution de l’EVA radiculalgie sera utilisée pour conclure sur l’efficacité des 2 traitements (Gabapentine ou Placebo).
    E.5.1.1Timepoint(s) of evaluation of this end point
    72 heures après administration du traitement.
    E.5.2Secondary end point(s)
    1/ Taux de patients présentant au moins un effet indésirable (tous types et grades) entre H0 et J7:
    Selon l’échelle National Cancer Institute Common terminology criteria for adverse events (NCI CTCAE) v4.0

    2/ Evolution de l’EVA lombalgie entre H0 et H72, et taux de répondeurs à H72 (= EVA douleur lombalgie < 40/100)

    3/ Evolution de l’EVA radiculalgie et de l’EVA lombalgie entre H0 et J7 (intervalle de temps comprenant H24, H48, et H72)

    4/ Evolution du NPSI (Neuropathic Pain Symptom Inventory) entre H0 et H72, puis entre H0 et J7

    5/ Evolution de l’EVA radiculalgie entre H0 et H72, puis entre H0 et J7, en fonction de la positivité initiale du dn4 (questionnaire de dépistage des douleurs neuropathiques)

    6/ Nombre d’interdoses d’antalgiques anti-nociceptifs entre H0 et H72 et taux de patients ayant recours à au moins une interdose entre H0 et H72

    7/ Taux de patients ayant réduit le traitement antalgique anti- nociceptif associé (diminution de posologie ou palier ou arrêt) entre H72 et J7

    8/ Liens entre consommation d’antidépresseurs et antiépileptiques (oui/non), et EVA douleur radiculalgie à H72, si les effectifs le permettent au sein du groupe Gabapentine
    E.5.2.1Timepoint(s) of evaluation of this end point
    1/ 7 jours après administration du traitement
    2/ 72 heures après administration du traitement
    3/ 24 heures, 48 heures, 72 heures et 7 jours après administration du traitement,
    4/ 72 heures après administration du traitement et 7 jours après administration du traitement
    5/ 72 heures après administration du traitement et 7 jours après administration du traitement
    6/ 72 heures après administration du traitement
    7/ 7 jours après administration du traitement
    8/ 72 heures après administration du traitement
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 concerned5
    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 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
    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 months36
    E.8.9.1In the Member State concerned days7
    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: 96
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 48
    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 state144
    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
    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 Decision2021-04-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-19
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat May 10 00:31:21 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA