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

MindMed

Status and phase: Completed; Phase 2

Conditions: Attention Deficit Disorder; ADHD

Treatments: Other: Placebo; Drug: MM-120

Study type: Interventional

Funder types: Industry

Identifiers

NCT05200936

MMED007

Details and patient eligibility

About

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

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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53 participants in 2 patient groups, including a placebo group

Arm 1- Placebo

Placebo Comparator group

Description:

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:

Other: Placebo

Arm 2- MM-120

Experimental group

Description:

A total of 26 patients will receive 20 μg of MM-120 administered orally twice weekly for 6 weeks.

Treatment:

Drug: MM-120