This Phase III, multicenter, randomised, double-blind, placebo-controlled trial (n=200) will evaluate the efficacy and safety of oral MM120 (LSD D-Tartrate) compared to placebo in adults with Generalized Anxiety Disorder (GAD). The study aims to assess changes in anxiety levels, primarily measured by the Hamilton Anxiety Rating Scale (HAM-A), over a 12-week period, followed by a 40-week open-label extension. Participants aged 18 to 74 years with a confirmed diagnosis of GAD and a minimum HAM-A score of 20 will be enrolled. The trial consists of a 12-week treatment phase where participants will receive either a single dose of 100 µg MM120 or a placebo, followed by a 40-week extension phase allowing for open-label treatment based on safety and symptom severity criteria. The study will monitor participants for changes in anxiety symptoms and overall safety throughout the trial duration.
A Phase 3 Double-blind, Placebo-controlled Study (Part A) with an Open-label Extension (Part B) Evaluating MM120 Compared to Placebo in Generalized Anxiety Disorder - Voyage
A substance that is designed to have no therapeutic value
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)