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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05200936
Recruitment Status : Recruiting
First Posted : January 21, 2022
Last Update Posted : June 21, 2022
Sponsor:
Information provided by (Responsible Party):
Mind Medicine, Inc.

Tracking Information
First Submitted Date  ICMJE December 21, 2021
First Posted Date  ICMJE January 21, 2022
Last Update Posted Date June 21, 2022
Actual Study Start Date  ICMJE December 17, 2021
Estimated Primary Completion Date September 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2022)
Change in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Symptoms [ Time Frame: 6 weeks ]
Mean change from baseline in Attention-Deficit/Hyperactivity Disorder (ADHD) Symptoms
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2022)
  • Changes in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Symptoms [ Time Frame: 6 weeks ]
    Change from baseline in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) after 1 week (2 doses) of treatment.
  • Number of patients who experience a decrease in the Clinical Global Impressions Scale (CGI-S) [ Time Frame: 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 [ Time Frame: 6 weeks ]
    Change from baseline in patient self-assessment by the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS)
  • Changes in patient self-assessment of Adult Attention-Deficit/Hyperactivity Disorder(ADHD) symptoms [ Time Frame: 6 weeks ]
    Change from baseline in patient self-assessment by the Connors' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (CAARS).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 7, 2022)
  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 10 weeks ]
    Psychological and/or clinical adverse events.
  • Pharmacokinetic Outcomes [ Time Frame: 6 weeks ]
    Maximum Plasma Concentration [Cmax] of MM-120 in the blood.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Low Dose MM-120 for ADHD Proof of Concept Trial
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • ADHD
  • Attention Deficit Disorder
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Placebo
  • Experimental: Arm 2- MM-120
    A total of 26 patients will receive 20 μg of MM-120 administered orally twice weekly for 6 weeks.
    Intervention: Drug: MM-120
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 7, 2022)
52
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 27, 2023
Estimated Primary Completion Date September 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mind Medicine +1 (332) 282-0479 mmed007@mindmed.co
Listed Location Countries  ICMJE Netherlands,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05200936
Other Study ID Numbers  ICMJE MMED007
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Mind Medicine, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Mind Medicine, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kim Kuypers Maastricht University
Principal Investigator: Matthias Liechti University Hospital, Basel, Switzerland
PRS Account Mind Medicine, Inc.
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP