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    Summary
    EudraCT Number:2022-003237-19
    Sponsor's Protocol Code Number:82695
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-03-02
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2022-003237-19
    A.3Full title of the trial
    The difference in pharmacodynamic and pharmacokinetic profiles between Tentin and generic dexamphetamine in adults with attention deficit hyperactivity disorder, a double-blinded randomized crossover-controlled trial
    Het verschil in farmacodynamische en farmacokinetische profielen tussen Tentin en generieke dexamfetamine bij volwassenen met aandachtstekortstoornis met hyperactiviteit, een dubbelblinde, gerandomiseerde, cross-over-gecontroleerde studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The difference in the mechanism of action between two brands of dexamfetamine in adults with ADHD.
    Het verschil in de werkingsmechanisme tussen twee merken dexamfetamine bij volwassenen met ADHD.
    A.3.2Name or abbreviated title of the trial where available
    DAVE-study
    DAVE-studie
    A.4.1Sponsor's protocol code number82695
    A.5.4Other Identifiers
    Name:CCMONumber:82695
    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 SponsorAmsterdam UMC
    B.1.3.4CountryNetherlands
    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 supportAmsterdam UMC
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportADHDcentraal
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmsterdam UMC, Location AMC
    B.5.2Functional name of contact pointDepartment of Clinical Pharmacology
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031205667048
    B.5.6E-maile.pirgon@amsterdamumc.nl
    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 Tentin
    D.2.1.1.2Name of the Marketing Authorisation holderMedice Arzneimittel Pütter GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameDexamfetamine
    D.3.2Product code N06BA02
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Attention Deficit Hyperactivity Disorder (ADHD)
    Aandachtstekort Hyperactiviteitstoornis (ADHD)
    E.1.1.1Medical condition in easily understood language
    Attention Deficit Hyperactivity Disorder (ADHD)
    Aandachtstekort Hyperactiviteitstoornis (ADHD)
    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 23.0
    E.1.2Level LLT
    E.1.2Classification code 10064104
    E.1.2Term ADHD
    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
    The primary objective is to compare the pharmacological profile of the generic form of dexamphetamine sulfate to the pharmacological profile of the brand-name form of dexamphetamine (Tentin©) in adult patients diagnosed with attention deficit hyperactivity disorder (ADHD) and assess whether there is a difference in absorption rate, dissolution rate, and effects between the two forms of dexamphetamine.

    Het primaire doel is om het farmacologische profiel van de generieke vorm van dexamfetaminesulfaat te vergelijken met het farmacologische profiel van het geregistreerde merk dexamfetamine (Tentin©) bij volwassen patiënten gediagnosticeerd met Attention Deficit Hyperactivity Disorder (ADHD) en te beoordelen of er een verschil in absorptiesnelheid, oplossnelheid en effecten tussen de twee vormen van dexamfetamine.
    E.2.2Secondary objectives of the trial
    The secondary objective is to assess how pharmacokinetic variability influences the objective and subjective (side) effects experienced by adult patients with ADHD.
    Het secundaire doel is om te beoordelen hoe de farmacokinetische variabiliteit de objectieve en subjectieve bijwerkingen en/of effectenvan dexamfetamine bij volwassen patiënten met ADHD beïnvloedt.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible to participate in this study, a subject must meet all the following criteria:
    - Participant is aged ≥ 18 years at time of screening.
    - Participant is diagnosed with ADHD according to the DSM 5 criteria.
    - Participant has switched from Tentin© to generic dexamphetamine due to the adverse effects of Tentin.
    - Participant is being treated adequately with dexamphetamine, as determined by their practitioner, at time of screening.
    - Participant or their legal representative is able and willing to provide written informed consent.
    - Participant is able and willing to comply with the study protocol (e.g. swallow capsules, have blood samples taken, can visit the outpatient clinic twice).
    - Participant has not participated in another study in the past three months.
    Om in aanmerking te komen voor deelname aan dit onderzoek, moet een proefpersoon aan alle volgende criteria voldoen:
    - Participant is op het moment van screenen ≥ 18 jaar oud.
    - Participant is gediagnosticeerd met ADHD volgens de DSM 5 criteria.
    - Participant is overgestapt van Tentin© naar generieke dexamfetamine vanwege de bijwerkingen van Tentin.
    - Participant wordt op het moment van screening adequaat behandeld met dexamfetamine, zoals voorgeschreven door de behandelaar.
    - Participant of diens wettelijke vertegenwoordiger is in staat en bereid om schriftelijke informed consent te geven.
    - Participant kan en wil zich aan het onderzoeksprotocol houden (bijvoorbeeld capsules slikken, bloed laten afnemen, tweemaal polikliniek bezoeken).
    - Participant heeft in de afgelopen drie maanden niet deelgenomen aan een ander onderzoek.
    E.4Principal exclusion criteria
    A potential subject who meets any of the following criteria will be excluded from participation in this study:
    - Participant is currently receiving other (psycho) pharmacotherapy treatment than dexamphetamine.
    - Participant has a disorder that might affect drug absorption (e.g. gastrointestinal, metabolic, endocrine or liver disorder).
    - Participant is allergic to the ingredients of the capsules.
    Een potentiële proefpersoon die aan een van de volgende criteria voldoet, wordt uitgesloten van deelname aan dit onderzoek:
    - Deelnemer krijgt momenteel een andere psychofarmacotherapeutische behandeling dan dexamfetamine.
    - Deelnemer heeft een aandoening die de absorptie van geneesmiddelen kan beïnvloeden (bijv. gastro-intestinale, metabole, endocriene of leveraandoening).
    - Deelnemer is allergisch voor de ingrediënten van de capsules.
    E.5 End points
    E.5.1Primary end point(s)
    - Quantified behavior Test for analysis of objective effects.
    - Blood samples for analysis of the plasma concentration of dexamphetamine.
    - Autonomic and adverse effects measurements (vital signs): Blood pressure and Heart rate
    - Quantified behavior Test (QbTest) voor het meten van objectieve effecten.
    - Bloedsamples voor de bepaling van de plasmaconcentratie dexamfetamine.
    - Meting van autonome effects en bijwerkingen (vitale functies): bloeddruk en hartslag.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At three moments (0, 60 and 120 minutes after drug administration) on each intervention-day, participants will complete the QbTest to assess objective performance and the QbPerformance to assess subjective performance.

    At eight moments (0, 45, 60, 75, 90, 120, 150 and 180 minutes after drug administration) on each intervention-day, participants will undergo blood sampling to determine dexamphetamine plasma concentrations and vital sign measurements for safety monitoring and possible outcome-effects.
    Op drie momenten (0, 60 en 120 minuten na toediening van het geneesmiddel) op elke interventiedag zullen de deelnemers de QbTest uitvoeren om de objectieve effecten te beoordelen en de QbPerformance om de subjectieve effecten te beoordelen.

    Op acht momenten (0, 45, 60, 75, 90, 120, 150 en 180 minuten na toediening van het geneesmiddel) op elke interventiedag ondergaan de deelnemers bloedafname om dexamfetamine plasmaconcentraties en worden de vitale functies gemeten voor veiligheidsmonitoring en mogelijke effecten op de uitkomstmaten.
    E.5.2Secondary end point(s)
    Subjective effects:
    - Addiction Research Centre Inventory (ARCI) - Amphetamine Scale (9-11)
    - Bond-Lader Visual Analog Scale (BL-VAS)
    - QbTest performance questionnaire
    Subjectieve effecten:
    - Addiction Research Centre Inventor (ARCI) - Amfetamineschaal
    - Bond-Lader Visual Analog Scale (BL-VAS)
    - QbTest performance questionnaire
    E.5.2.1Timepoint(s) of evaluation of this end point
    At eight moments (0, 45, 60, 75, 90, 120, 150 and 180 minutes after drug administration) on each intervention-day, participants will fill out questionnaires to assess subjective experiences.
    Op acht momenten (0, 45, 60, 75, 90, 120, 150 en 180 minuten na toediening van het geneesmiddel) op elke interventiedag vullen de deelnemers vragenlijsten in om de subjectieve effecten te beoordelen.
    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 No
    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) 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 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 Yes
    E.8.2.3.1Comparator description
    Magistraal bereidde dexamfetamine
    Generic dexamfetamine
    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 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
    The end of the study is defined as "after the last patient’s last visit".
    Het einde van het onderzoek wordt gedefinieerd als "na het laatste bezoek van de laatste patiënt".
    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 months3
    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: 26
    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 state26
    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
    Geen
    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 Decision2023-03-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-04-03
    P. End of Trial
    P.End of Trial StatusOngoing
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