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

Sponsor
Mind Medicine, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05200936
Collaborator
(none)
52
2
2
23.3
26
1.1

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Dec 17, 2021
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Nov 27, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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)

  3. 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)

  4. 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).

Other Outcome Measures

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [10 weeks]

    Psychological and/or clinical adverse events.

  2. Pharmacokinetic Outcomes [6 weeks]

    Maximum Plasma Concentration [Cmax] of MM-120 in the blood.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Maastricht University Maastricht Netherlands
2 University Hospital Basel Basel Switzerland

Sponsors and Collaborators

  • Mind Medicine, Inc.

Investigators

  • Principal Investigator: Kim Kuypers, Maastricht University
  • Principal Investigator: Matthias Liechti, University Hospital, Basel, Switzerland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mind Medicine, Inc.
ClinicalTrials.gov Identifier:
NCT05200936
Other Study ID Numbers:
  • MMED007
First Posted:
Jan 21, 2022
Last Update Posted:
Jun 21, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 21, 2022