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    The EU Clinical Trials Register currently displays   43875   clinical trials with a EudraCT protocol, of which   7295   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:2021-005326-23
    Sponsor's Protocol Code Number:PHRC-K2020PEZET
    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:2021-11-10
    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 number2021-005326-23
    A.3Full title of the trial
    Evaluation of the efficacy of donepezil in the treatment of oxaliplatin-induced peripheral neuropathy: proof of concept study
    EVALUATION DE L’EFFICACITE DU DONEPEZIL DANS LE TRAITEMENT DES NEUROPATHIES PERIPHERIQUES INDUITES PAR L’OXALIPLATINE
    Etude preuve de concept
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the efficacy of donepezil in the treatment of oxaliplatin-induced peripheral neuropathy
    EVALUATION DE L’EFFICACITE DU DONEPEZIL DANS LE TRAITEMENT DES NEUROPATHIES PERIPHERIQUES INDUITES PAR L’OXALIPLATINE
    A.3.2Name or abbreviated title of the trial where available
    DONEPEZOX
    DONEPEZOX
    A.4.1Sponsor's protocol code numberPHRC-K2020PEZET
    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 SponsorCHU de Clermont-Ferrand
    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 supportInstitut National du Cancer (INCa)
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Clermont-Ferrand
    B.5.2Functional name of contact pointDRCI
    B.5.3 Address:
    B.5.3.1Street Address58 rue montalembert
    B.5.3.2Town/ cityClermont-Ferrand
    B.5.3.3Post code63000
    B.5.3.4CountryFrance
    B.5.6E-mailggouby@chu-clermontferrand.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 Donepezil
    D.2.1.1.2Name of the Marketing Authorisation holderMYLAN
    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 nameDONEPEZIL
    D.3.4Pharmaceutical form Tablet
    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 placeboTablet
    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
    Oxaliplatine-induced peripheral neuropathy
    Neuropathie périphérique induite par l'oxaliplatine
    E.1.1.1Medical condition in easily understood language
    Oxaliplatine-induced peripheral neuropathy
    Neuropathie périphérique induite par l'oxaliplatine
    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
    assess the therapeutic efficacy of donepezil on the severity of oxaliplatin-induced peripheral neuropathy (responder rate using QLQ-CIPN20 sensory score, comparison before and after treatment) in CRC patient survivors who have received adjuvant oxaliplatin-based chemotherapy.
    Evaluer l'efficacité thérapeutique du donépézil sur la sévérité des neuropathies périphériques induites par l'oxaliplatine (taux de répondeur en utilisant le score sensitif du questionnaire QLQ-CIPN20, comparaison avant vs après traitement), chez des patients survivants d’un cancer colorectal et ayant reçu une chimiothérapie adjuvante à base d'oxaliplatine.
    E.2.2Secondary objectives of the trial
    Efficacité du donépézil : comparaison avant vs après le traitement, et comparaison vs groupe placebo, pour l'amélioration de :
    - Symptômes neuropathiques (score QLQ-CIPN20 et taux de répondeur),
    - Grade de neuropathie périphérique (NCI-CTCAE),
    - Douleur neuropathique (NRS douleur + questionnaire DN4 interview) si présente (questionnaire NPSI),
    - Qualité de vie reliée à la santé (questionnaire QLQ-C30),
    - Ressenti du patient sur l’efficacité du traitement (PGIC),
    - Anxiété et dépression (questionnaire HADS),
    - Consommation d'analgésiques.
    Evaluation de la tolérance du traitement (type, intensité, fréquence des effets indésirables et taux de sortie en raison d'effets indésirables).
    Efficacy of donepezil, before and after treatment and compared to a placebo, for the improvement of:
    - Neuropathic symptoms throughout the study (QLQ-CIPN20 score and responder rate),
    - Peripheral neuropathy grade (NCI-CTCAE),
    - Neuropathic pain (NRS pain + DN4 interview), if pain ≥ 4/10 (NPSI questionnaire),
    - Health-related quality of life (QLQ-C30 questionnaire),
    - Patient global impression of change (PGIC)
    - Anxiety and depression (HADS questionnaire),
    - Consumption of painkillers.

    - Safety (type, intensity, frequency of adverse effects and exit rates due to adverse effects).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age ≥18 years,
    - Male / Female,
    - Patient who received adjuvant chemotherapy with oxaliplatin (FOLFOX/CAPOX/XELOX), for stage II/III CRC,
    - QLQ-CIPN20 sensory score ≥30 (equivalent to the NCI-CTCAE grade of neuropathy ≥2),
    - Diagnosis of OIPN treated or not by stable antineuropathic/analgesic treatment (opioids, pregabalin, gabapentin, duloxetine and other antidepressants or anticonvulsants) for at least 1 month,
    - Chemotherapy completed for at least 3 months,
    - Patients affiliated to the French national health insurance,
    - Written informed consent,
    - French language comprehension.
    - Consentement éclairé signé, obtenu préalablement à toute procédure spécifique à l’étude
    - Homme / Femme ≥18 ans
    - Patient ayant reçu une chimiothérapie adjuvante à base d'oxaliplatine pour le traitement d’un cancer colorectal de stade II/III
    - Score sensitif du QLQ-CIPN20 ≥30 (= grade de neuropathie NCI-CTCAE ≥2)
    - Diagnostic de neuropathie périphérique induite par l'oxaliplatine, traitée ou non par un traitement antineuropathique/antalgique stable (opioïdes, prégabaline, gabapentine, duloxétine et autres antidépresseurs ou anticonvulsivants) depuis au moins 1 mois
    - Chimiothérapie terminée depuis au moins 3 mois
    - Patients affiliés à l'assurance maladie française
    E.4Principal exclusion criteria
    - Rechute du cancer
    - Patient atteint d'une maladie chronique progressive (à l'exclusion de la neuropathie périphérique induite par l'oxaliplatine)
    - Autres types de neuropathies non liées à la chimiothérapie
    - ALAT / ASAT supérieur de plus de 3 fois les valeurs normales
    - Maladies cardiovasculaires graves (selon avis du clinicien), bradycardie (<55 bpm), troubles de la conduction cardiaque telle que maladie du sinus ou d'autres anomalies de la conduction supra-ventriculaire telles qu’un bloc sino-auriculaire ou auriculo-ventriculaire (évaluation par électrocardiogramme)
    - Antécédents de maladie ulcéreuse ou ulcère gastroduodénal actif
    - Asthme ou maladie pulmonaire obstructive
    - Allergie connue aux dérivés du donépézil ou de la pipéridine
    - Interactions médicamenteuses : Inhibiteurs du CYP3A4 (kétoconazole, itraconazole et érythromycine) ; inhibiteurs du CYP2D6 (fluoxétine) et inducteurs enzymatiques (rifampicine, phénytoïne, carbamazépine)
    - Intolérance connue au galactose, déficit connu en lactase de Lapp ou syndrome de malabsorption du glucose ou du galactose (maladies héréditaires rares) connu
    - Dépendance à l'alcool et/ou aux drogues connue
    - Troubles psychotiques connus, patient sous antipsychotiques
    - Autre cancer concomitant
    - Grossesse ou allaitement (contraception obligatoire)
    - Personne sous tutelle, sous curatelle, et sauvegarde de justice ou personne privée de liberté
    - Impossibilité de se soumettre au suivi médical de l’essai pour des raisons géographiques, sociales ou psychiques
    - Cancer relapse,
    - Pregnancy or breastfeeding (contraception is mandatory),
    - Patient with chronic progressive disease (excluding OIPN),
    - Other types of neuropathies not related to chemotherapy,
    - ALAT / ASAT more than 3 times the normal values,
    - Serious cardiovascular disease (as determined by the clinician), bradycardia (<55 bpm), cardiac conduction disorders such as sinus disease or other supra-ventricular conduction abnormalities such as sino-auricular or atrioventricular block (evaluation by electrocardiogram),
    - History of active ulcer disease or peptic ulcer disease,
    - Asthma or obstructive lung disease,
    - Known allergy to donepezil or piperidine derivatives,
    - Drug Interactions: CYP3A4 inhibitors (ketoconazole, itraconazole and erythromycin); CYP2D6 inhibitors (fluoxetine) and enzyme inducers (rifampin, phenytoin, carbamazepine),
    - Known galactose intolerance, known Lapp lactase deficiency or known glucose or galactose malabsorption syndrome (rare hereditary diseases),
    - Known dependence on alcohol and/or drugs,
    - Known psychotic disorders, patient on antipsychotics.
    E.5 End points
    E.5.1Primary end point(s)
    The QLQ-CIPN20 questionnaire (EORTC) is a 20-item self-administered questionnaire that was developed specifically to assess patients' experience of symptoms and functional limitations due to their chemo-induced peripheral neuropathy (CIPN). The QLQ-CIPN20 is divided into 3 subscales: sensory, motor and vegetative and provides a comprehensive picture of the nature, frequency and severity of the CIPN.
    The sensitive subscale of the QLQ-CIPN20, which will be our main criterion of judgment, explores a wide range of symptoms, including paresthesia, dysesthesia, neuropathic pain and also numbness, which are the majority of CIPN symptoms.
    This questionnaire has been validated by two large international clinical trials.
    Le questionnaire QLQ-CIPN20 (EORTC) est un questionnaire auto-administré en 20 points qui a été développé spécifiquement pour évaluer l'expérience des patients en matière de symptômes et de limitations fonctionnelles dus à leur neuropathie périphérique chimio-induite (CIPN). Le QLQ-CIPN20 est divisé en 3 sous-échelles : sensorielle, motrice et végétative et fournit une image complète de la nature, de la fréquence et de la gravité de la CIPN.
    La sous-échelle sensitive du QLQ-CIPN20, qui sera notre principal critère de jugement, explore un large éventail de symptômes, notamment les paresthésies, les dysesthésies, les douleurs neuropathiques mais aussi les engourdissements, qui constituent la majorité des symptômes du CIPN.
    Ce questionnaire a été validé par deux grands essais cliniques internationaux.
    E.5.1.1Timepoint(s) of evaluation of this end point
    16 weeks
    16 semaines
    E.5.2Secondary end point(s)
    - Peripheral neuropathy grade (NCI-CTCAE),
    - Neuropathic pain (11-point NRS pain + DN4 interview), if pain ≥ 4/10 (NPSI questionnaire),
    - Health-related quality of life (QLQ-C30 questionnaire),
    - Patient global impression of change (PGIC),
    - Anxiety and depression (HADS questionnaire).
    - Grade de neuropathie périphérique (NCI-CTCAE),
    - Douleur neuropathique (douleur NRS 0-10 + entretien DN4), si douleur ≥ 4/10 (questionnaire NPSI),
    - Qualité de vie liée à la santé (questionnaire QLQ-C30),
    - Impression globale du changement par le patient (PGIC),
    - Anxiété et dépression (questionnaire HADS).
    E.5.2.1Timepoint(s) of evaluation of this end point
    monthly
    mensuel
    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) 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.8.2.4Number 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 concerned26
    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
    Dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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: 80
    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 state80
    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)
    In the case of a beneficial therapeutic effect at the end of the treatment (significant reduction of neuropathic disorders according to QLQ-CIPN20 and the opinion of both patient and clinician), the investigator will be authorized to ask for the blinded treatment to be lifted in order to prescribe it (not covered by the MA and not paid by the sponsor) and/or to refer the patient to a specialist (neurologist, pain physician).
    En cas d'effet thérapeutique bénéfique à l'issue du traitement (réduction significative des troubles neuropathiques selon le QLQ-CIPN20 et l'avis du patient et du clinicien), l'investigateur sera autorisé à demander la levée d'aveugle du traitement afin de le prescrire (non pris en charge par l'AMM et non payé par le promoteur) et/ou à orienter le patient vers un spécialiste (neurologue, médecin de la douleur).
    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 Decision2022-01-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-01-24
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