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

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

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

Study Overview

• Status: Completed
• Conditions: ADHD; Attention Deficit Disorder
• Intervention / Treatment: Other: Placebo; Drug: MM-120

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 Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Mind Medicine; Phone Number: +1 (332) 282-0479; Email: mmed007@mindmed.co

Study Locations

• Netherlands
  • Maastricht, Netherlands
    • Maastricht University
• Switzerland
  • Basel, Switzerland
    • University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Arm 1- 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.	Other: Placebo; A treatment which is designed to have no therapeutic value.
Experimental: Arm 2- MM-120; A total of 26 patients will receive 20 μg of MM-120 administered orally twice weekly for 6 weeks.	Drug: MM-120; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Psychological and/or clinical adverse events.	10 weeks
Pharmacokinetic Outcomes	Maximum Plasma Concentration [Cmax] of MM-120 in the blood.	6 weeks

Collaborators and Investigators

• Sponsor: Mind Medicine, Inc.
• Investigators: Principal Investigator: Matthias Liechti, University Hospital, Basel, Switzerland; Principal Investigator: Kim Kuypers, Maastricht University

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2021
• Primary Completion (Actual): November 6, 2023
• Study Completion (Actual): December 4, 2023

Study Registration Dates

• First Submitted: December 21, 2021
• First Submitted That Met QC Criteria: January 7, 2022
• First Posted (Actual): January 21, 2022

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: MMED007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No