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    Summary
    EudraCT Number:2021-005596-39
    Sponsor's Protocol Code Number:MPELONG
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-03-11
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2021-005596-39
    A.3Full title of the trial
    Long-Term Safety and Persistence of Effectiveness of Manualized MDMA Assisted Therapy for the Treatment of Posttraumatic Stress Disorder
    Dlouhodobé sledování bezpečnosti a persistence MDMA-asistované terapie k léčbě posttraumatické stresové poruchy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-term follow-up of safety and effectiveness of MDMA-assisted therapy for posttraumatic stress disorder
    Dlouhodobé sledování bezpečnosti a persistence MDMA-asistované terapie k léčbě posttraumatické stresové poruchy
    A.3.2Name or abbreviated title of the trial where available
    Long-term follow-up of MDMA-assisted therapy for PTSD
    Dlouhodobé sledování MDMA-asistované terapie k léčbě PTSD
    A.4.1Sponsor's protocol code numberMPELONG
    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 number312021 01363
    B.5.5Fax numberNA
    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 HCI
    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.3.9.4EV Substance CodeSUB190531
    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)
    Posttraumatická stresová porucha (PTSP)
    E.1.1.1Medical condition in easily understood language
    post-traumatic stress disorder, PTSD, Trauma
    Posttraumatická stresová porucha, PTSP, 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
    Comparison of PTSD severity between groups who received MDMA vs. Placebo during parent study based on LTFU IR assessment (Visit 1)
    Porovnání závažnosti PTSD mezi skupinami, které dostávaly MDMA vs. placebo během rodičovské studie na základě hodnocení LTFU IR (nezávislým hodnotitelem) (Návštěva 1)
    E.2.2Secondary objectives of the trial
    Comparison of degree of functional impairment associated with PTSD between groups who received MDMA vs. Placebo during parent study based on LTFU IR assessment (Visit 1)
    Porovnání stupně funkčního poškození spojeného s PTSD mezi skupinami, které dostávaly MDMA vs. placebo během rodičovské studie na základě hodnocení LTFU IR (Návštěva 1)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. At least 18 years of age at the time of signing the informed consent.
    2. Previously enrolled in a MAPS Europe sponsored study of MDMA assisted therapy for the treatment of PTSD.
    3. Have received at least one dose of Investigational Medicinal Product (IMP) in the parent study.
    4. Agree to be contacted by a study team at least 6 months after the last Experimental Session in the parent study to schedule and participate in LTFU assessments.
    5. Agree to have Independent Rater assessments video-recorded.
    6. Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
    1. Věk nejméně 18 let v době podpisu informovaného souhlasu.
    2. Dřívější zařazení do studie sponzorované organizací MAPS Europe týkající se MDMA-asistované terapie pro léčbu PTSD.
    3. Užití alespoň jedné dávky zkoušeného léčivého přípravku (IMP) v rámci rodičovské studie.
    4. Souhlas s kontaktováním studijním týmem nejméně 6 měsíců po ukončení rodičovské studie za účelem naplánování a účasti na hodnocení LTFU.
    5. Souhlas s pořízením videozáznamu při hodnocení nezávislým hodnotitelem.
    6. Schopnost dát písemený informovaný souhlas, jak je popsáno v příloze 1, který zahrnuje dodržování požadavků a omezení uvedených ve formuláři informovaného souhlasu (IS) a v tomto protokolu.
    E.4Principal exclusion criteria
    1. Have any current problem which, in the opinion of the investigator or Medical Monitor, might interfere with study participation.
    1. Objevení jakéhokoliv aktuálního problému, který by podle názoru zkoušejícího nebo lékařského monitora mohl narušit účast ve studii.
    E.5 End points
    E.5.1Primary end point(s)
    CAPS-5 (Clinician-Administered PTSD Scale for Diagnostic and
    Statistical Manual of Mental Disorders, 5th edition)
    Total Severity Score
    Celkové skóre závažnosti CAPS-5 (Klinicky administrovaná Škála PTSD dle DSM_5) a Statistický manuál pro mentální poruchy.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 1
    Návštěva 1
    E.5.2Secondary end point(s)
    SDS (Sheehan Disability Scale) for PTSD for MAPS Total score
    Celkové skóre SDS pro PTSD pro MAPS (Přizpůsobená verze Sheehanovy Stupnice Nezpůsobilosti pro PTSD pro studie MAPS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 1
    Návštěva 1
    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 Yes
    E.6.13.1Other scope of the trial description
    Long term follow-up
    Dlouhodobé sledování
    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 No
    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 Yes
    E.8.1.7.1Other trial design description
    Studie dlouhodobého sledování , není podáván žádný hodnocený léčivý přípravek
    Long term follow-up study, no IMP given
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA6
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Czechia
    Germany
    Netherlands
    Norway
    United Kingdom
    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
    LSLV
    poslední návštěva posledního účastníka
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 No
    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
    Subjects with PTSD
    Účastníci/ce s PTSD
    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 29
    F.4.2.2In the whole clinical trial 37
    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)
    At Study Termination, participants will be provided with post-study plan. This plan will summarize treatments completed, current medications, and contact information for more information about the study if needed. Participants may request a referral for further therapeutic or medical care if appropriate. Enrolled participants who
    terminate the study early will be offered a post-study plan at their last contact. Screen Failures will be provided a referral if requested.
    Na ukončovací návštěvě bude s účastníkem dohodnut po-studijní plán.
    Tento plán je souhrn dokončené léčby, aktuální medikace a kontaktních údajů pro další informace o studii, pokud je to potřeba. Účastníci mohou v případě potřeby požádat o doporučení pro další terapeutickou nebo lékařskou péči. Zařazeným účastníkům, kteří předčasně ukončili studii, bude nabídnut po-studijní plán při posledním kontaktu. V případě neúspěšného screeningu bude poskytnuto doporučení, pokud bude požadováno.
    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 Decision2022-05-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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