First Session Conducted in 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 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 and first MDMA-assisted therapy session! Data gathered in European trials is required for a planned Marketing Authorization Application to the European Medicines Agency (EMA). 

On Friday, April 9, the first MDMA-assisted therapy session for the study took place in The Netherlands. The second participant’s first experimental session is planned for the coming weeks. The second site in The Netherlands has a long list of potential participants for phone screening, which starts soon.  

At our Czech Republic site, after several challenges with finding eligible patients, we finally have two promising participants; the first one has been initially enrolled and the second participant is expected to be initially enrolled in the coming days, meanwhile phone screening is ongoing to find another patient.

At our site in Norway, the study team are regrouping after their first participant was unfortunately unable to progress to the first experimental session and so has dropped out of the study recently. The team have identified three further potential participants who are expected to be screened in the coming weeks.

Further study sites in Germany, the UK and Portugal are all in start-up and are hoped to begin patient recruitment before the end of Summer 2021.