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: January 2021 Update

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. 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 and the Netherlands are currently screening participants, screening at the Norway site and the second Netherlands site is expected to begin early in 2021. 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 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