Phase 2
Completed N=53
Safety and Efficacy of Low Dose MM120 for ADHD Proof of Concept Trial
Attention Deficit Hyperactivity Disorder · Attention Deficit Disorder
Source: ClinicalTrials.gov NCT05200936 ↗
Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcomePrimary: Change in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Symptoms — 37.4; 37.3; 29.6; 29.0 units on a scale — p=0.7145
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Symptoms |
37.4; 37.3; 29.6; 29.0 | 0.7145 |
| SECONDARY Changes in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Symptoms |
37.5; 36.9; 34.2; 32.1 | 0.9613 |
| SECONDARY Number of Patients Who Experience a Decrease in the Clinical Global Impressions Scale (CGI-S) |
8; 11; 16; 15; 17; 12 | — |
| SECONDARY Change From Baseline in in Clinical Global Impressions Scale (CGI-S) |
4.9; 4.7; 4.6; 4.3; 4.9; 4.8 | — |
| SECONDARY Adult Attention-deficit/Hyperactivity Disorder Self-reporting Rating Scale (ASRS) |
48.0; 43.9; 40.2; 36.7; 48.6; 44.6 | — |
| SECONDARY Change From Baseline in Connors' Adult ADHD Rating Scale (CAARS) |
-4.0; -2; -6.9; -3.6; -5.6; -4.6 | — |
| SECONDARY 5 Dimensions of Altered States of Consciousness Questionnaire (5D-ASC) Scores |
479.6; 161.3; 103.6; 19.0; 233.4; 94.8 | — |
| SECONDARY Mystical Experience Questionnaire 30 Items (MEQ30) |
22.37; 10.40; 20.50; 5.20 | — |
| SECONDARY Summary of Drug Effects Visual Analog Scale (VAS) |
0; 0; 37.1; 44.9; 2.7; 1.4 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT05200936). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.