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

ADHD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05200936
• Other study ID #: MMED007
• Status: Completed
• Phase: Phase 2
• Start date: December 17, 2021
• Est. completion date: December 4, 2023

Study information

• Verified date: January 2024
• Source: Mind Medicine, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 4, 2023
• Est. primary completion date: November 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder
• Attention Deficit Disorder with Hyperactivity

Intervention

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.

Other:
• Placebo
A treatment which is designed to have no therapeutic value.

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht
Switzerland	University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Mind Medicine, Inc.

Countries where clinical trial is conducted

Netherlands,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Psychological and/or clinical adverse events.	10 weeks
Other	Pharmacokinetic Outcomes	Maximum Plasma Concentration [Cmax] of MM-120 in the blood.	6 weeks
Primary	Change in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Symptoms	Mean change from baseline in Attention-Deficit/Hyperactivity Disorder (ADHD) Symptoms	6 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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