Safety and Efficacy of Low Dose MM120 for ADHD Proof of Concept Trial

NCT05200936 | Completed Phase 2 Results DMC

• 1 other identifier: MMED007
• Study Type: interventional
• Target: 53
• Locations: 2 countries
• Sites: 2

Brief Summary

This study measures the safety and efficacy of repeated low dose MM120 as treatment for ADHD in adults: a multi-center, randomized, double-blind, placebo-controlled

Conditions

ADHD; Attention Deficit Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Symptoms

  The Adult ADHD investigator symptom rating scale (AISRS) total score consists of 18 items from the original Attention-deficit/hyperactivity Disorder Rating Scale (ADHD-RS). The ADHD-RS includes 9 items that address symptoms of inattention, and 9 items that address symptoms of impulsivity and hyperactivity. Each item is rated from 0 to 3. The AISRS total score can range from 0 to 54. A higher score corresponds to a worse severity of ADHD.

  6 weeks

Secondary Outcomes (8)

• Changes in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Symptoms

  Week 2

• Number of Patients Who Experience a Decrease in the Clinical Global Impressions Scale (CGI-S)

  Baseline, Week 2, Week 6, Week 10

• Change From Baseline in in Clinical Global Impressions Scale (CGI-S)

  Baseline, Week 2, Week 6

• Adult Attention-deficit/Hyperactivity Disorder Self-reporting Rating Scale (ASRS)

  6 weeks

• Change From Baseline in Connors' Adult ADHD Rating Scale (CAARS)

  6 weeks

Other Outcomes (4)

• Pharmacokinetic Outcomes

  0.5, 1, 2, 3, 4, 6 hours post-dose

• Pharmacokinetic Parameters (Cmax)

  0.5, 1, 2, 3, 4, 6 hours post-dose

• Pharmacokinetic Parameters (Tmax and t1/2)

  0.5, 1, 2, 3, 4, 6 hours post-dose

Study Arms (2)

Arm 1- Placebo

PLACEBO COMPARATOR

A total of 26 patients will receive a placebo identical in appearance to the investigational medicinal product (IMP) administered orally twice weekly (e.g., Tuesday/Friday) for 6 weeks.

Other: Placebo

Arm 2- MM120

EXPERIMENTAL

A total of 26 patients will receive 20 μg of MM120 administered orally twice weekly for 6 weeks.

Drug: MM120

Interventions

MM120 DRUG

MM120 is a psychedelic drug that can cause intensified thoughts, emotions, and sensory perception. At sufficiently high dosages MM120 manifests primarily visual, as well as auditory, hallucinations.

Also known as: MM-120, DT120, lysergide tartrate

Arm 2- MM120

Placebo OTHER

A treatment which is designed to have no therapeutic value.

Arm 1- Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female outpatients ≥ 18 and ≤ 65 years of age at Screening
• Patients with the diagnosis of Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) ADHD, as determined by clinical evaluation and confirmed by structured interview (MINI).
• Adequate organ function.
• Able to understand the study procedures and understand risks associated with the study, and sign written informed consent to participate in the study.
• Must be willing to refrain from more than 6 standard alcoholic drinks a week, more than 10 cigarettes a day, and more than 2 cups of coffee a day throughout the study treatment period (6 weeks) and until the last study visit is complete.

You may not qualify if:

• Past or present diagnosis of a primary psychotic disorder or first degree relative with a psychotic disorder.
• Past or present bipolar disorder (DSM-5).
• Any lifetime history of suicide attempt.
• Once Informed Consent form is signed, not willing or able to stop any prescription or non-prescription ADHD medications.
• Use of investigational medication/treatment in the past 30 days.
• Patients with a positive urine drug screen with the exception of THC or its metabolites.
• Pregnant or nursing females.

Sponsors & Collaborators

• Definium Therapeutics US, Inc.: lead

Study Sites (2)

Maastricht University

Maastricht, Netherlands

Location

University Hospital Basel

Basel, Switzerland

Location

Related Publications (1)

• Mueller L, Santos de Jesus J, Schmid Y, Muller F, Becker A, Klaiber A, Straumann I, Luethi D, Haijen ECHM, Hurks PPM, Kuypers KPC, Liechti ME. Safety and Efficacy of Repeated Low-Dose LSD for ADHD Treatment in Adults: A Randomized Clinical Trial. JAMA Psychiatry. 2025 Jun 1;82(6):555-562. doi: 10.1001/jamapsychiatry.2025.0044.

  PMID: 40105807 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Limitations and Caveats

Although a multicenter-trial, one site enrolled 95% of participants. Only twice-weekly dose regimen was tested, which may not account for interindividual variability in response. Finally, other outcomes such as emotion regulation were not addressed.

Results Point of Contact

• Title: Medical Affairs
• Organization: Definium Therapeutics US, Inc.

MedAffairs@definiumtx.com

1-332-245-4732

Study Officials

• Kim Kuypers

  Maastricht University

  PRINCIPAL INVESTIGATOR

• Matthias Liechti

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 21, 2022
• Study Start: December 17, 2021
• Primary Completion: November 6, 2023
• Study Completion: December 4, 2023
• Last Updated: February 27, 2026
• Results First Posted: April 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); CH (1)