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    Summary
    EudraCT Number:2018-001718-13
    Sponsor's Protocol Code Number:MP18
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-01-15
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2018-001718-13
    A.3Full title of the trial
    An Open- Label, Phase 2, Multicenter Feasibility Study if Manualized MDMA-Assisted Psychotherapy with an fMRI sub-study Assessing Changes in Brain Activity in Subjects with Posttraumatic Stress Disorder.
    Een open label, multicentrisch, fase 2 haalbaarheidsonderzoek naar MDMA geassisteerde psychotherapie volgens een handleiding met een optionele fMRI substudie ter beoordeling van de veranderingen in de hersenactiviteit bij proefpersonen met post-traumatische stressstoornis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MDMA-Assisted Psychotherapy for the Treatment of PTSD
    MDMA-geassisteerde psychotherapie voor de behandeling van PTSS
    A.4.1Sponsor's protocol code numberMP18
    A.5.4Other Identifiers
    Name:ClinicalTrials.gov Number:NCT04030169
    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 SponsorMAPS Europe B.V.
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMAPS Europe B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMAPS Europe B.V.
    B.5.2Functional name of contact pointFabiana da Silva Alves
    B.5.3 Address:
    B.5.3.1Street AddressPO Box 71352
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1008 BJ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031202101363
    B.5.6E-mailfabiana@mapseurope.eu
    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 No
    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 name3,4-methylenedioxymethamphetamine hydrochloride
    D.3.2Product code MDMA HCl
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMidomafetamine
    D.3.9.1CAS number 42542-10-9
    D.3.9.2Current sponsor codeMDMA HCl
    D.3.9.3Other descriptive name3,4-METHYLENEDIOXYMETHAMPHETAMINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB20716
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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.IMP: 2
    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 No
    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 name3,4-methylenedioxymethamphetamine hydrochloride
    D.3.2Product code MDMA HCl
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMidomafetamine
    D.3.9.1CAS number 42542-10-9
    D.3.9.2Current sponsor codeMDMA HCl
    D.3.9.3Other descriptive name3,4-METHYLENEDIOXYMETHAMPHETAMINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB20716
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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
    post-traumatic stress disorder (PTSD)
    posttraumatische stressstoornis (PTSS)
    E.1.1.1Medical condition in easily understood language
    post-traumatic stress disorder, PTSD, Trauma
    posttraumatische stressstoornis, PTSS, Trauma
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    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
    The overall objective of this study is to use standard clinical measures to
    explore the safety and effects of open-label manualized MDMA-assisted
    psychotherapy with a flexible dose of MDMA in participants with severe
    PTSD, and to serve as an opportunity for supervision of therapy teams
    selected to conduct Phase 3 MDMA-assisted psychotherapy research.
    The primary objective of this study is to evaluate the effectiveness of
    MDMA-assisted psychotherapy for treatment of PTSD, as measured by
    the estimand of change in CAPS-5 Total Severity Score
    Het primaire doel van deze studie is het evalueren van het effect van MDMA-geassisteerde psychotherapie op PTSS, gemeten aan de hand van de verandering in CAPS-5 totale ernstscore
    E.2.2Secondary objectives of the trial
    The secondary objective is to evaluate the effectiveness of MDMAassisted
    psychotherapy for PTSD in clinician-rated functional
    impairment, as measured by the mean change in Sheehan Disability
    Scale (SDS) item scores.
    Safety Objective
    The overall safety objective is to assess severity, incidence and
    frequency of AEs, AEs of Special Interest (AESIs), and Serious Adverse
    Events (SAEs), concomitant medication use, suicidal ideation and
    behavior, and vital signs to support the package insert for MDMAassisted
    psychotherapy.
    Het secundaire doel is het evalueren van de effectiviteit van MDMA-geassisteerde psychotherapie voor PTSS op een klinisch gescoorde functionele beperking, gemeten aan de hand van de gemiddelde verandering in Sheehan Disability Scale (SDS) scores.

    Veiligheidsdoelstelling
    De algemene veiligheidsdoelstelling is om de ernst, incidentie en frequentie van ongewenste voorvallen, ongewenste voorvallen van speciaal belang, ernstige ongewenste voorvallen, gelijktijdig gebruik van medicatie, suïcidale gedachten en suïcidaal gedrag en vitale functies te beoordelen ter ondersteuning van de bijsluiter voor MDMA-geassisteerde psychotherapie.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    An Open- Label, Phase 2, Multicenter Feasibility Study if Manualized MDMA-Assisted Psychotherapy with an fMRI sub-study Assessing Changes in Brain Activity in Subjects with Post-Traumatic Stress Disorder

    Version 6.0, 29MAR2021

    The fMRI Sub-Study will explore possible biological correlates of treatment outcomes obtained from MDMA-assisted psychotherapy among participants with PTSD:
    - To investigate pre-post effects of MDMA-assisted psychotherapy on brain function and connectivity as measured by functional magnetic resonance imaging (fMRI) and magnetic resonance spectroscopy (MRS), including response to trauma-unrelated emotional stimuli (emotional faces), response to trauma symptom provocation (personal trauma narrative). The outcome variables will be compared between timepoints (Baseline scan and post-treatment scan).
    - To examine the relationship between fMRI outcome variables and the primary outcome variable, namely change in CAPS-5 Total Severity Score from Baseline to post Baseline.
    Een open label, multicentrisch, fase 2 haalbaarheidsonderzoek naar MDMA geassisteerde psychotherapie volgens een handleiding met een optionele fMRI substudie ter beoordeling van de veranderingen in de hersenactiviteit bij proefpersonen met post-traumatische stressstoornis

    Versie 6.0, 29MAR2021
    fMRI-deelstudie zal de mogelijke biologische correlaten van de behandelresultaten van MDMA-geassisteerde psychotherapie bij proefpersonen met PTSS onderzoeken:
    - Het onderzoeken van pre-post effecten van MDMA-geassisteerde psychotherapie op de hersenfunctie en connectiviteit zoals gemeten door functionele magnetische resonantie beeldvorming (fMRI) en magnetische resonantie spectroscopie (MRS), inclusief respons op niet-trauma-gerelateerde emotionele stimuli (emotionele gezichten) en respons op trauma symptoom provocatie (persoonlijk traumaverhaal). De uitkomstvariabelen zullen worden vergeleken tussen tijdspunten (baseline scan en post-behandeling scan).
    - Het onderzoeken van de relatie tussen fMRI-uitkomstvariabelen en de primaire uitkomstvariabele, namelijk verandering in CAPS-5 totale ernstscore van baseline tot na baseline .
    E.3Principal inclusion criteria
    - Are at least 18 years old
    - Are fluent in speaking and reading the predominantly used or
    recognized language of the study site
    - Are able to swallow pills
    - Agree to have study visits video-recorded, including Experimental
    Sessions, Independent Rater assessments, and non-drug psychotherapy
    sessions
    - Must provide a contact (relative, spouse, close friend or other support
    person) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable
    - Must agree to inform the investigators within 48 hours of any medical
    treatments and procedures
    - People able to become pregnant (PABP) (i.e., assigned female at birth, fertile, following menarche and until becoming post-menopausal unless permanently sterile), must have a highly sensitive negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate birth control through 10 days after the last Experimental Session. Adequate birth control methods include intrauterine device (IUD), injected or implanted hormonal methods, abstinence, oral hormones plus a barrier contraception, vasectomized sole partner (described in more detail in Section 10.3.2 Contraception Guidelines).
    - Agree to the following lifestyle modifications: comply with
    requirements for fasting and refraining from certain medications prior to Experimental Sessions, not enroll in any other interventional clinical trials during the duration of the study, remain overnight at the study site
    after each Experimental Session and be driven home after, and commit to medication dosing, therapy, and study procedures.
    - At Screening, meet DSM-5 criteria for current PTSD
    - May have well-controlled hypertension that has been successfully treated with anti-hypertensive medicines, if they pass additional screening to rule out underlying cardiovascular disease
    - May have asymptomatic Hepatitis C virus (HCV) that has previously undergone evaluation and treatment as needed.

    For the MRI sub-study
    - Absence of Traumatic Brain Injury
    - Absence of metal implants or metal fragments in the body
    - PTSD must be of non-dissociative sub-type
    - Absence of claustrophobia
    - Absence of tattoos in the head/neck or permanent eye makeup
    - Proefpersonen ≥ 18 jaar
    - Is vloeiend in het spreken en lezen van de overwegend gebruikte of herkende taal van de studiesite
    - Kan pillen slikken
    - Gaat ermee akkoord dat er video-opnames van de studiebezoeken worden gemaakt, inclusief de experimentele sessies, evaluaties van de onafhankelijke beoordelaar en de niet-medicamenteuze psychotherapiesessies.
    - Moet de gegevens van een contactpersoon (familielid, echtgenoot, goede vriend of ander steunfiguur) doorgeven met wie de onderzoekers contact op kunnen nemen indien de proefpersoon suïcidaal of onbereikbaar wordt.
    - Moet ermee instemmen dat hij/zij de onderzoekers binnen 48 uur op de hoogte stelt van medische behandelingen en procedures.
    - Mensen die zwanger kunnen worden (dat wil zeggen, vruchtbaar zijn, vrouw zijn bij geboorte, na de menarche en tot postmenopauze, tenzij ze permanent zijn gesteriliseerd), moeten een negatieve zwangerschapstest hebben bij aanvang van het onderzoek en voorafgaand aan elke experimentele sessie, en moeten akkoord gaan met het gebruik van adequate anticonceptie tot 10 dagen na de laatste experimentele sessie. Adequate anticonceptiemethoden omvatten intra-uterien apparaat (IUD), geïnjecteerde of geïmplanteerde hormonale methoden, onthouding, orale hormonen plus een barrière-anticonceptie, vaste partner die vasectomie heeft ondergaan.
    - Gaat akkoord met de volgende leefstijlveranderingen: voldoen aan de vereisten voor vasten en afzien van bepaalde medicijnen voorafgaand aan de experimentele sessies, niet inschrijven aan andere klinische onderzoeken tijdens de studie, na iedere experimentele sessie ’s nachts op de studiesite verblijven en de volgende dag naar huis gereden worden, en zich toeleggen op de medicatiedosering, therapie en onderzoeksprocedures.
    - Mag bij screening een gecontroleerde hypertensie hebben die succesvol behandeld is met bloeddrukverlagende medicatie. Bij aanvullende screening moeten onderliggende cardiovasculaire aandoeningen zijn uitgesloten.
    - Mag bij screening asymptomatische Hepatitis C-virus (HCV) hebben dat eerder is beoordeeld en behandeld.

    MRI sub-studie
    - Afwezigheid van traumatisch hersenletsel;
    - Afwezigheid van metalen implantaten of metaalfragmenten in het lichaam;
    - PTSS moet een niet-dissociatief subtype zijn;
    - Afwezigheid van claustrofobie;
    - Afwezigheid van tatoeages op het hoofd of in de nek, en permanente oogmake-up.
    E.4Principal exclusion criteria
    - Are not able to give adequate informed consent
    - Have any current problem which, in the opinion of the investigator or
    Medical Monitor, might interfere with participation
    - Would present a serious risk to others as established through clinical
    interview and contact with treating psychiatrist
    - Require ongoing concomitant therapy with a psychiatric medication
    with exceptions described in the protocol.
    - Weigh less than 48 kilograms (kg)
    - Are pregnant or nursing or are of childbearing potential and are not
    practicing an effective means of birth control.
    - Is niet in staat informed consent te geven.
    - Heeft momenteel een probleem dat, naar oordeel van de onderzoeker of medische monitor, deelname zou kunnen verstoren.
    - Zou een ernstig risico vormen voor anderen, welke is vastgesteld via een klinisch interview en contact met de behandelende psychiater.
    - Vereist voortdurende, gelijktijdige therapie met een psychiatrisch medicijn. Uitzonderingen staan beschreven in het protocol.
    - Weegt < 48 kilogram (kg).
    - Is zwanger, geeft borstvoeding, of kan zwanger worden en maakt geen gebruik van een effectieve anticonceptiemethode.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of this study is to evaluate the effectiveness of MDMA-assisted psychotherapy for treatment of PTSD, as measured by the estimand of change in CAPS-5 Total Severity Score.
    Het primaire doel van deze studie is het evalueren van het effect van MDMA-geassisteerde psychotherapie op PTSS, gemeten aan de hand van de verandering in CAPS-5 totale ernstscore.
    E.5.1.1Timepoint(s) of evaluation of this end point
    13 weeks post baseline
    13 weken na baseline
    E.5.2Secondary end point(s)
    The secondary objective is to evaluate the effectiveness of MDMA-assisted psychotherapy for PTSD in clinician-rated functional impairment, as measured by the mean change in Sheehan Disability Scale (SDS) item scores.
    Het secundaire doel is het evalueren van de effectiviteit van MDMA-geassisteerde psychotherapie voor PTSS op een klinisch gescoorde functionele beperking, gemeten aan de hand van de gemiddelde verandering in Sheehan Disability Scale (SDS) scores.
    E.5.2.1Timepoint(s) of evaluation of this end point
    13 weeks post baseline
    13 weken na baseline
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    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 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 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 No
    E.8.2.3Other No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months14
    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: 32
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    PTSD
    PTSS
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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 Decision2019-01-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-12-15
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    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
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