Safety and Efficacy of Low Dose MM-120 for ADHD Proof of Concept Trial

The Phase IIa trial, conducted at Maastricht University and University Hospital Basel, involved 53 patients diagnosed with ADHD. These patients were randomized in a 1:1 ratio to receive either a placebo or MM-120 (MindMed), which is a low-dose form of d-lysergic acid diethylamide (LSD) D-tartrate. In this trial, patients in the active arm were administered 20 μg of LSD orally, twice weekly for 6 weeks. This dosage, at the upper end of a microdose, represents about 20% of the dose typically used for recreational psychedelic purposes.

However, Mind Medicine (MindMed), the study’s sponsor, recently announced that this trial failed to meet its primary endpoint, and no further details were provided on the outcome. This announcement came as part of a broader ‘Business Update and Anticipated Milestones’ press release.

In light of these results and findings from a study of MM-120 in Generalized Anxiety Disorder (GAD), MindMed has made a strategic decision to shelve its sub-perceptual LSD program. The emerging understanding of the importance of the perceptual effects of MM-120 in mediating clinical responses informs this decision.

Participants include male and female outpatients aged 18 to 65 years, diagnosed with ADHD according to DSM-5 criteria, and meet specific inclusion criteria such as adequate organ function and the ability to understand study procedures. Exclusion criteria include a past or present diagnosis of a primary psychotic disorder, bipolar disorder, any history of a suicide attempt, and certain medication use.

This study was conducted at multiple centers, including Maastricht University in the Netherlands and the University Hospital Basel in Switzerland. The principal investigators are Kim Kuypers from Maastricht University and Matthias Liechti from University Hospital, Basel, Switzerland.

Trial Details

This study is a multi-centre, randomized, double-blind, placebo-controlled Phase 2a study of low dose MM-120 (20 μg) compared with a placebo administered for 6 weeks (twice a week on a 3/4-day schedule). Low dose MM-120 (20 μg) is about 20% of the dose typically consumed for recreational psychedelic purposes. There will be a 1:1 randomization, double-blind, to MM-120 or placebo with the aim to reach 26 evaluable patients in each of the 2 arms at Week 6.

NCT Number NCT05200936

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