Trial results for MM120 (LSD D-Tartrate) in a Phase 2 dose-finding study for generalized anxiety disorder were posted on ClinicalTrials.gov on 2025-03-20. The study demonstrated a dose-response relationship, with the 100 µg dose showing a statistically significant difference from placebo (p-value: 0.0004) in reducing anxiety symptoms.
Background
This study investigated MM120 (LSD D-Tartrate) as a potential treatment for anxiety symptoms in subjects diagnosed with generalized anxiety disorder (GAD).
Trial design
The study (NCT05407064) was a Phase 2, multi-center, randomized, double-blind, parallel-group, dose-finding study. It enrolled 198 participants diagnosed with generalized anxiety disorder. The trial assessed the effect of four doses of MM120 (25, 50, 100, or 200 μg freebase-equivalent) compared to placebo. The primary endpoint was evaluated by determining if there was a dose-response relationship between the change from baseline to Week 4 and Week 8 in total HAM-A score and the dose administered, using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology.
Key results
The trial evaluated dose response across different treatment arms, measuring the mean change from baseline in units on a scale:
- For Arm 1 (Placebo), the mean change was -14.23 units.
- For Arm 2 (25 μg MM-120), the mean change was -15.35 units.
- For Arm 3 (50 μg MM-120), the mean change was -16.05 units.
- For Arm 4 (100 μg MM-120), the mean change was -19.22 units.
- For Arm 5 (200 μg MM-120), the mean change was -20.09 units.
Further analyses using ANCOVA determined the difference in Least Squares (LS) Mean from placebo for change from baseline. The p-values for these differences were:
- For 25 μg MM-120 vs. placebo: 0.1157
- For 50 μg MM-120 vs. placebo: 0.663
- For 100 μg MM-120 vs. placebo: 0.0004
- For 200 μg MM-120 vs. placebo: 0.01
What this means
The results from this Phase 2 dose-finding study suggest that MM120 (LSD D-Tartrate) demonstrates a dose-response relationship in reducing anxiety symptoms in patients with generalized anxiety disorder. Specifically, the 100 µg and 200 µg doses showed statistically significant improvements compared to placebo, indicating potential efficacy for these higher doses. These findings support further investigation of MM120 as a therapeutic option for GAD.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05407064, titled "A Dose-Finding Study of MM120 (LSD D-Tartrate) for the Treatment of Anxiety Symptoms," were posted on 2025-03-20 on clinicaltrials.gov.