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CompletedPhase 2

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

Key facts

Who runs it
Definium Therapeutics US, Inc.
Where
Netherlands and Switzerland2 sites in 2 countriesChoose a country to see its sites
Trial code
Status
Completed
Phase
Phase 2
People taking part
53 people enrolled
Started
17 Dec 2021
Ended
4 Dec 2023
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • MM120
  • Placebo
Record updated
27 February 2026

Who can take part

Age
18 years to 65 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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
  • Pregnant or nursing females

This trial has no sites in United States.

It has sites in 2 countries. Choose a country to see its sites.

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • Arm 1- PlaceboPlacebo, for comparison

    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.

    Treatment: Placebo

  • Arm 2- MM120Treatment being tested

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

    Treatment: MM120

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Safety and Efficacy of Repeated Low Dose d-Lysergic Acid Diethylamide (LSD) D-tartrate (MM120) as Treatment for ADHD in Adults: a Multi-center, Randomized, Double-blind, Placebo-controlled Phase 2a Proof of Concept Trial
Publications
Record updated
27 February 2026