An Open-Label, Phase 2, Multicenter Feasibility Study of Manualized MDMA-Assisted Therapy with an Optional fMRI Sub-Study Assessing Changes in Brain Activity in Subjects with Posttraumatic Stress Disorder

Taking place in the United Kingdom, Germany, Portugal, Norway, the Czech Republic, and the Netherlands, this open-label Phase 2 study of MDMA-assisted psychotherapy for PTSD will serve as the lead-in to the planned Phase 3 study in Europe providing an opportunity for clinical supervision of therapy teams to complete their training, and to validate assumptions made for statistical power calculations supporting the planned Phase 3 clinical trial. This study will also provide cross-cultural validation data on the updated version of the Primary Outcome measure, the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), which will be used in the Phase 3 study. In addition, the study will gather supportive data on the safety and effectiveness of manualized MDMA-assisted psychotherapy.. This study will be the first multi-center study of MDMA-assisted psychotherapy for PTSD in Europe and will explore reproducibility of findings from FDA-regulated Phase 2 and Phase 3 trials to confirm the Phase 3 study design.

The study site in the Czech Republic is currently screening participants, screening at the first of two Netherlands sites will begin imminently, and screening at the Norway site is expected to start before the end of the year. The sites in the United Kingdom and Germany require further permissions before they can begin screening, most likely in early 2021, and the study set-up in Portugal is still in an early stage. Data gathered in European trials would provide support for a planned Marketing Authorization Application for potential approval by the European Medicines Agency (EMA). For more information, please visit: our webpage.