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    Summary
    EudraCT Number:2013-002996-16
    Sponsor's Protocol Code Number:ANRSSHS155STIMAGO
    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:2015-06-17
    Trial results View 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 number2013-002996-16
    A.3Full title of the trial
    ANRS SHS155 STIMAGO: Pilote study to evaluate the benefits and the risks of methylphenidate for the treatment of cocain dependence.
    ANRS SHS155 STIMAGO : Etude pilote pour l’évaluation des bénéfices et des risques du méthylphénidate pour la prise en charge de la dépendance à la cocaïne.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ANRS SHS155 STIMAGO: Pilote study to evaluate the benefits and the risks of methylphenidate for the treatment of cocain dependence.
    ANRS SHS155 STIMAGO : Etude pilote pour l’évaluation des bénéfices et des risques du méthylphénidate pour la prise en charge de la dépendance à la cocaïne.
    A.3.2Name or abbreviated title of the trial where available
    ANRS SHS155 STIMAGO
    ANRS SHS155 STIMAGO
    A.4.1Sponsor's protocol code numberANRSSHS155STIMAGO
    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 SponsorInserm-ANRS
    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 supportANRS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInserm U912
    B.5.2Functional name of contact pointPerrine Roux
    B.5.3 Address:
    B.5.3.1Street Address23 rue Stanislas Torrents
    B.5.3.2Town/ cityMarseille
    B.5.3.3Post code13006
    B.5.3.4CountryFrance
    B.5.6E-mailperrine.roux@inserm.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 Concerta LP 18 mg
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Cilag
    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.3.4Pharmaceutical form Prolonged-release 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cocaine dependence
    Dépendance à la cocaïne
    E.1.1.1Medical condition in easily understood language
    Cocaine dependence
    Dépendance à la cocaïne
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10009817
    E.1.2Term Cocaine dependence
    E.1.2System Organ Class 100000004873
    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 effective dose of a psycho-stimulant, methylphenidate, as a treatment for cocaine dependence in terms of risks/benefits (toxicity and reduction in cocaine use).
    Evaluer la dose efficace d’un psychostimulant, le méthylphénidate (MPH), dans la prise en charge de la dépendance à la cocaïne en termes de bénéfice/risque (toxicité et réduction de la consommation de cocaïne).
    E.2.2Secondary objectives of the trial
    - To measure cocaine abstinence 3 months after initiation of treatment.
    - To measure the reduction of HCV risk practices, subjective effects of treatment, craving, psychiatric comorbidities (depression and ADHD), criminal acts, quality of life, social reinsertion, access to care…
    - Etudier l’abstinence à la cocaïne 3 mois après le début du traitement.
    - Etudier la réduction des pratiques à risque VHC, les effets subjectifs du traitement, le craving, les comorbidités psychiatriques (dépression et troubles de l’attention), les actes de délinquance, la qualité de vie, la réinsertion sociale, l’accès aux soins…
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Aged between 18 and 64 years old.
    • Diagnosed with cocaine/crack dependence using DSM IV (and CIM 10) and willing to be abstinent.
    • Having a cocaine/crack positive urinary test.
    • Willing to participate.
    • Being able to give consent
    • Patient majeur de 18 à 64 ans.
    • Présentant une dépendance à la cocaïne ou au crack selon le DSM IV (et la CIM 10) et exprimant le désir d'être abstinent.
    • Avoir un test urinaire à la cocaïne/crack positif.
    • Volontaire pour participer à l'essai.
    • Etre en mesure de donner un consentement éclairé.
    E.4Principal exclusion criteria
    • Dependence on alcohol and/or other substances.
    • Hypersensitivity to the active compound methylphenidate or to filler.
    • Glaucoma.
    • Phaeochromocytoma
    • Family history or diagnosis of Gilles de la Tourette syndrome.
    • During treatment with non-selective, irreversible monoamine oxidase (MAO) inhibitors.
    • History of hyperthyroidism or of thyrotoxicosis.
    • Preexisting cardiovascular problems including severe hypertension, heart failure, arterial occlusive disease, angina, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening arrythmias and channelopathies, (disorders caused by the dysfunction of ionic channels).
    • Preexisting cerebrovascular disorders, cerebral aneurism, vascular abnormalities including vasculitis or stroke.
    • Diagnosis or history of severe depression, anorexia nervosa or anorexic disorders.
    • Suicidal tendencies or characterized suicidal syndrome.
    • Pregnancy, breast-feeding or absence of any contraception for female participants.
    • Unstabilized psychiatric comorbidity likely to compromise adherence to treatment.
    • Comorbidity or handicap likely to corrupt evaluation. Organic pathology severe enough according to the investigator, likely to comprise adequate surveillance during the trial.
    • Patient about to leave the area for a period of time preventing his/her adequate participation in the trial.
    • Insufficient motivation.
    • Participation in another clinical trial with an on-going exclusion period at the time of the pre-inclusion visit.
    • Lack of medical insurance.
    • Unreachable by phone.
    • Patient on mandatory treatment.
    • Patient with legal incapacity (under guardianship/curatorship).
    • Patient kept in detention.
    • Dépendance alcoolique ou à une autre substance.
    • Hypersensibilité connue au principe actif (chlorhydrate de MPH) ou à l'un des excipients.
    • Glaucome.
    • Phéochromocytome.
    • Antécédents familiaux ou diagnostic de syndrome de Gilles de la Tourette.
    • Patient prenant des IMAO.
    • Antécédent d'hyperthyroïdie ou de thyrotoxicose.
    • Troubles cardiovasculaires préexistants incluant hypertension sévère, insuffisance cardiaque, artériopathie occlusive, angine de poitrine, cardiopathie congénitale avec retentissement hémodynamique; cardiomyopathie, infarctus du myocarde, arythmies et canalopathies (troubles causés par un dysfonctionnement des canaux ioniques) pouvant potentiellement mettre en jeu le pronostic vital.
    • Préexistence de troubles cérébrovasculaires, anévrisme cérébral, anomalies vasculaires, y compris vascularite ou accident vasculaire cérébral.
    • Antécédents ou diagnostic de dépression sévère, d’anorexie mentale ou de troubles anorexiques.
    • Idées suicidaires caractérisées ou syndrome suicidaire caractérisé.
    • Patiente enceinte, allaitante, ou en âge de procréer en l'absence de contraception efficace.
    • Pathologie psychiatrique non stabilisée pouvant compromettre l'observance.
    • Maladie associée ou handicap pouvant fausser les évaluations ou une pathologie organique suffisamment grave pour ne pas permettre le suivi dans l'étude selon l'avis de l'investigateur.
    • Absence prévue qui pourrait entraver la participation à l’essai (voyage à l’étranger, déménagement, mutation imminente …).
    • Motivation insuffisante.
    • Personne participant à une autre recherche comprenant une période d’exclusion toujours en cours à la pré-inclusion
    • Patient sans couverture sociale.
    • Patient en injonction thérapeutique.
    • Patient en incapacité majeure (tutelle/curatelle).
    • Patient privé de liberté.
    E.5 End points
    E.5.1Primary end point(s)
    • Difference between weekly cocaine use at M0 and M3.
    • Différence de quantité de consommation hebdomadaire de cocaïne entre M0 et M3.
    E.5.1.1Timepoint(s) of evaluation of this end point
    • Cocaine use at Month 3
    • Consommation de cocaine à M3
    E.5.2Secondary end point(s)
    Number of perceived side effects.
    Craving, Cocaine abstinence ; Reduction in HCV risk practices ; Reduction in psychiatric symptoms (score CES-D, score ADHD) : Reduction in criminal behaviors ; Increase of quality of life score ; Increase of socio-professional reinsertion level.
    Nombre d’effets secondaires perçus
    Craving
    Abstinence à la cocaïne
    Diminution des pratiques à risque de transmission du VHC
    Diminution des symptomes psychiatriques (score CES-D, score ADHD)
    Diminution des actes de délinquance
    Amélioration du score de qualité de vie
    Amélioration du niveau d'insertion socio-professionnelle
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluation at M1, M2 and M3
    Evaluation à M1, M2 et M3
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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
    Dernière visite de la dernière personne participant à l'essai.
    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 months9
    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: 20
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state20
    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)
    Given that Concerta has a MA in France for a different indication than cocaine dependence, patients will be able to continue the treatment under the condition of having an authorization. This decision will be discussed by the patient and the physician together.
    Le Concerta bénéficiant d'une AMM en France dans le cadre d'une autre indication, il sera possible de proposer au patient de continuer son traitement avec une autorisation. Ce point sera discuté entre le patient et son médecin.
    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 Decision2014-08-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-06-30
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