Trial results for MM120 (LSD D-Tartrate) in a Phase 2 proof-of-concept study for Attention-Deficit/Hyperactivity Disorder (ADHD) in adults were posted on ClinicalTrials.gov on 2025-04-13. The study, which evaluated repeated low doses of MM120, showed no statistically significant improvement in ADHD symptoms compared to placebo, with p-values of 0.7145 and 0.9613 for key analyses.
Background
The study investigated MM120 (LSD D-Tartrate) as a potential treatment for Attention-Deficit/Hyperactivity Disorder (ADHD) in adults. This Phase 2 trial was designed as a proof-of-concept study to assess the safety and efficacy of repeated low doses.
Trial design
The study, NCT05200936, was a Phase 2, multi-center, randomized, double-blind, placebo-controlled trial. It enrolled 53 adult participants diagnosed with ADHD or Attention Deficit Disorder. The trial aimed to measure the safety and efficacy of repeated low-dose MM120 as a treatment for ADHD in adults, comparing it against a placebo arm.
Key results
The trial evaluated several outcome measures related to ADHD symptoms. For the outcome titled "Change in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Symptoms":
- In one set of measurements, the MM120 arm showed a mean of 37.4 units on a scale (Standard Deviation: 6.11), while the placebo arm showed a mean of 37.3 units on a scale (Standard Deviation: 5.24).
- In another set of measurements for the same outcome, the MM120 arm showed a mean of 29.6 units on a scale (Standard Deviation: 8.27), compared to the placebo arm's mean of 29.0 units on a scale (Standard Deviation: 8.47).
For the outcome "Changes in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Symptoms":
- One measurement showed the MM120 arm with a mean of 37.5 units on a scale (Standard Deviation: 5.76), and the placebo arm with a mean of 36.9 units on a scale (Standard Deviation: 5.10).
- Another measurement showed the MM120 arm with a mean of 34.2 units on a scale (Standard Deviation: 6.49), while the placebo arm had a mean of 32.1 units on a scale (Standard Deviation: 4.96).
Regarding the outcome "Number of Patients Who Experience a Decrease in the Clinical Global Impressions Scale (CGI-S)":
- In one instance, 8 Participants in the MM120 arm experienced a decrease, compared to 11 Participants in the placebo arm.
- In another instance, 16 Participants in the MM120 arm experienced a decrease, compared to 15 Participants in the placebo arm.
Statistical analyses indicated no significant differences between the treatment arms. A Mixed Models Analysis yielded a p-value of 0.7145, and an ANCOVA analysis yielded a p-value of 0.9613.
What this means
The results from this Phase 2 proof-of-concept trial for MM120 (LSD D-Tartrate) in adults with ADHD indicate that the drug did not demonstrate a statistically significant improvement in measured ADHD symptoms or clinical global impressions compared to placebo. The observed mean changes in symptom scales and the number of responders were similar between the MM120 and placebo groups, as reflected by the high p-values from the statistical analyses. These findings suggest that repeated low-dose MM120, as studied in this trial, did not meet its efficacy endpoints for ADHD.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05200936, titled "Safety and Efficacy of Low Dose MM120 for ADHD Proof of Concept Trial," were posted on 2025-04-13 on clinicaltrials.gov.