Taking place in the United Kingdom, Germany, Portugal, Norway, the Czech Republic, and the Netherlands, this open-label Phase 2 study of MDMA-assisted therapy 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. We still have major fundraising to do for our EMA research effort. If anyone has suggestions for possible donors in Europe, we’d greatly appreciate suggestions or connections sent to email@example.com
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 therapy. This study will be the first multi-center study of MDMA-assisted therapy 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.
Study sites in the Czech Republic, Norway and the Netherlands are currently screening participants, and the second Netherlands site is expected to begin screening in March 2021. The sites in the United Kingdom and Germany require further permissions before they can begin screening, most likely in mid-2021, and the study set-up in Portugal is still at an early stage. Data gathered in European trials is hoped to provide support for a planned Marketing Authorization Application for potential approval by the European Medicines Agency (EMA). We are working on the regulatory submission for this study. • Learn More