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

Study Overview
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Brief Summary
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This study measures the safety and efficacy of repeated low dose MM-120 as treatment for ADHD in adults: a multi-center, randomized, double-blind, placebo-controlled

Detailed Description
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This study is a multi-center, 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.

Official Title
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Safety and Efficacy of Repeated Low Dose d-Lysergic Acid Diethylamide (LSD) D-tartrate (MM-120) as Treatment for ADHD in Adults: a Multi-center, Randomized, Double-blind, Placebo-controlled Phase 2a Proof of Concept Trial

Conditions
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ADHD, Attention Deficit Disorder

Intervention / Treatment
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* Drug: MM-120
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Arm 1- Placebo<br>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<br>* A treatment which is designed to have no therapeutic value.<br>|
| Experimental: Arm 2- MM-120<br>A total of 26 patients will receive 20 μg of MM-120 administered orally twice weekly for 6 weeks. | Drug: MM-120<br>* MM-120 is a psychedelic drug that can cause intensified thoughts, emotions, and sensory perception. At sufficiently high dosages MM-120 manifests primarily visual, as well as auditory, hallucinations.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Symptoms | Mean change from baseline in Attention-Deficit/Hyperactivity Disorder (ADHD) Symptoms | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Symptoms | Change from baseline in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) after 1 week (2 doses) of treatment. | 6 weeks | 
| Number of patients who experience a decrease in the Clinical Global Impressions Scale (CGI-S) | Occurrence of patients who experience at least a 1-point decrease in the Clinical Global Impressions Scale (CGI-S) | 6 weeks | 
| Changes in patient self-assessment of Adult attention-Deficit/Hyperactivity Disorder (ADHD) symptoms | Change from baseline in patient self-assessment by the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) | 6 weeks | 
| Changes in patient self-assessment of Adult Attention-Deficit/Hyperactivity Disorder(ADHD) symptoms | Change from baseline in patient self-assessment by the Connors' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (CAARS). | 6 weeks |