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    Summary
    EudraCT Number:2018-001718-13
    Sponsor's Protocol Code Number:MP18
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-09-29
    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 ConcernedSpain - AEMPS
    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.
    Estudio abierto de viabilidad multicéntrico de fase 2 sobre la psicoterapia asistida por MDMA estandarizada junto con estudio complementario opcional de RMF que evalúa los cambios en la actividad cerebral en sujetos con trastorno de estrés postraumático
    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
    Psicoterapia asistida con MDMA para el tratamiento del TEPT
    A.4.1Sponsor's protocol code numberMP18
    A.5.4Other Identifiers
    Name:ClinicalTrials.govNumber: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 pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressPaxlaan 10, Unit #142
    B.5.3.2Town/ cityHoofddorp
    B.5.3.3Post code2131 PZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031202101363
    B.5.6E-maillegalrep@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)
    Trastorno de estrés postraumático (TEPT)
    E.1.1.1Medical condition in easily understood language
    post-traumatic stress disorder (PTSD)
    Trastorno de estrés postraumático (TEPT)
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10036316
    E.1.2Term Post-traumatic stress disorder
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    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
    El objetivo general de este estudio consiste en utilizar medidas clínicas estándar para explorar la seguridad y la eficacia de la psicoterapia abierta y estandarizada asistida por MDMA con una dosis flexible de MDMA en participantes con TEPT grave. De igual modo, pretende servir de oportunidad para que los equipos terapéuticos seleccionados puedan supervisar e investigar la psicoterapia asistida por MDMA de fase 3. El objetivo principal de este estudio consiste en evaluar la eficacia de la psicoterapia asistida por MDMA para el tratamiento del TEPT, tomando como medida la estimación del cambio en la escala de gravedad total CAPS-5
    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.
    El objetivo secundario consiste en evaluar la eficacia de la psicoterapia asistida por MDMA para el TEPT en lo relativo al deterioro funcional evaluado por el profesional clínico, tomando como medida el cambio medio en las puntuaciones de las categorías de la escala de discapacidad de Sheehan.

    El objetivo general de seguridad consiste en evaluar la gravedad, la incidencia y la frecuencia de los acontecimientos adversos, los acontecimientos adversos de interés especial (AAIE) y los acontecimientos adversos graves (AAG), el uso de medicamentos concomitantes, las ideas de suicidio y el comportamiento suicida, así como los signos vitales con el fin de respaldar las instrucciones de uso de la psicoterapia asistida por MDMA
    E.2.3Trial contains a sub-study No
    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.
    - Tener al menos 18 años de edad
    - Hablan y leen con fluidez la lengua predominantemente utilizada o
    lengua predominantemente utilizada o reconocida en el lugar del estudio
    - Son capaces de tragar píldoras
    - Aceptan que se graben en vídeo las visitas del estudio, incluidas las sesiones experimentales
    experimentales, las evaluaciones del evaluador independiente y las sesiones de psicoterapia
    sesiones de psicoterapia
    - Deben proporcionar un contacto (pariente, cónyuge, amigo íntimo u otra persona de apoyo) que esté dispuesto y sea capaz de
    persona de apoyo) que esté dispuesta y sea capaz de ser localizada por los investigadores en caso de que el participante tenga tendencias suicidas o esté ilocalizable
    - Deben aceptar informar a los investigadores en un plazo de 48 horas de cualquier
    tratamientos y procedimientos médicos
    - Las personas con capacidad para quedarse embarazadas (PABP) (es decir, asignadas como mujeres al nacer, fértiles, después de la menarquia y hasta convertirse en posmenopáusicas, a menos que sean permanentemente estériles), deben tener una prueba de embarazo negativa de alta sensibilidad al entrar en el estudio y antes de cada sesión experimental, y deben aceptar utilizar un método anticonceptivo adecuado hasta 10 días después de la última sesión experimental. Los métodos anticonceptivos adecuados incluyen un dispositivo intrauterino (DIU), métodos hormonales inyectados o implantados, abstinencia, hormonas orales más un anticonceptivo de barrera, vasectomía de la única pareja (descrita con más detalle en la sección 10.3.2 Directrices sobre anticoncepción).
    - Aceptar las siguientes modificaciones del estilo de vida: cumplir con
    cumplir con los requisitos de ayuno y abstenerse de ciertos medicamentos antes de las Sesiones Experimentales, no inscribirse en ningún otro ensayo clínico de intervención durante la duración del estudio, pasar la noche en el lugar del estudio
    después de cada Sesión Experimental y ser conducido a casa después, y comprometerse a la dosificación de la medicación, la terapia y los procedimientos del estudio.
    - En el momento de la selección, cumplir los criterios del DSM-5 para el TEPT actual
    - Pueden tener una hipertensión bien controlada que haya sido tratada con éxito con medicamentos antihipertensivos, si superan un cribado adicional para descartar una enfermedad cardiovascular subyacente
    - Puede tener el virus de la hepatitis C (VHC) asintomático que haya sido previamente evaluado y tratado según sea necesario.
    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.
    - No son capaces de dar un consentimiento informado adecuado
    - Tienen algún problema actual que, en opinión del investigador o del
    Monitor médico, pueda interferir con la participación
    - Presenten un riesgo grave para los demás, tal como se ha establecido a través de la entrevista clínica y el contacto con el psiquiatra tratante.
    entrevista clínica y el contacto con el psiquiatra tratante
    - Requieren una terapia concomitante en curso con una medicación psiquiátrica
    con las excepciones descritas en el protocolo.
    - Pesan menos de 48 kilogramos (kg)
    - Están embarazadas o en período de lactancia, o están en edad fértil y no
    practican un medio eficaz de control de la natalidad.
    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.
    El objetivo principal de este estudio es evaluar la eficacia de la psicoterapia asistida con MDMA para el tratamiento del TEPT, medida por la estimación del cambio en la puntuación total de gravedad del CAPS-5.
    E.5.1.1Timepoint(s) of evaluation of this end point
    13 weeks post baseline
    13 semanas tras basal
    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.
    El objetivo secundario es evaluar la eficacia de la psicoterapia asistida con MDMA para el TEPT en el deterioro funcional calificado por el clínico, medido por el cambio medio en las puntuaciones de los ítems de la Escala de Discapacidad de Sheehan (SDS).
    E.5.2.1Timepoint(s) of evaluation of this end point
    13 weeks post baseline
    13 semanas tras basal
    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 concerned1
    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
    última visita del último paciente
    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 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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    PTSD
    TEPT
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    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
    Ninguno
    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 Decision2022-09-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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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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