First Participant Completes Second Experimental Session in Open-Label, Phase 2, Multicenter Feasibility Study of Manualized MDMA-Assisted Psychotherapy with an Optional fMRI Sub-Study Assessing Changes in Brain Activity in Subjects with PTSD in Europe
We are very excited to share updates for the open-label lead-in study of MDMA-assisted therapy for PTSD in Europe, including news about enrollment progress. Data gathered in European trials is required for a planned Marketing Authorization Application to the European Medicines Agency (EMA).
In early May, the first participant completed the second experimental MDMA-assisted therapy session at our first study site in the Netherlands. This participant is expected to complete their final study visit within the next few weeks. The second participant at this study site has completed their first experimental session and is on track to complete the second experimental session at the end of May. Screening has begun for potential patients at our second study site in Maastricht, Netherlands.
Our study site in the Czech Republic currently has its first potential participant in the screening process, and screening additional potential patients is ongoing.
At our study site in Norway, the research team is continuing to screen potential patients. Two participants are currently at various stages in the screening process. If any are eligible to proceed, the first experimental session is expected to take place in mid-June.
Further study sites in Germany, the UK, and Portugal are starting and are expected to begin patient recruitment before the end of summer 2021.