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

Phase 2

Completed

• Conditions: Attention Deficit Disorder; ADHD
• Interventions: Drug: MM-120; Other: Placebo

• Registration Number: NCT05200936
• Lead Sponsor: Mind Medicine, Inc.

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-12-17
• Study First Submitted: 2021-12-21
• Study First Submitted QC: 2022-01-07
• Study First Posted: 2022-01-21
• Primary Completion: 2023-11-06
• Study Completion: 2023-12-04
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-12
• Last Update Posted: 2024-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2- MM-120	MM-120	A total of 26 patients will receive 20 μg of MM-120 administered orally twice weekly for 6 weeks.
Arm 1- Placebo	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Change in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Symptoms	6 weeks	Mean change from baseline in Attention-Deficit/Hyperactivity Disorder (ADHD) Symptoms

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Maastricht University; 🇳🇱 Maastricht, Netherlands

University Hospital Basel; 🇨🇭 Basel, Switzerland