Back to resultsSafety and Efficacy of Low Dose MM-120 for ADHD Proof of Concept Trial
Primary Purpose
ADHD, Attention Deficit Disorder
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MM-120
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for ADHD
Eligibility Criteria
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.
Sites / Locations
- Maastricht University
- University Hospital BaselRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Arm 1- Placebo
Arm 2- MM-120
Arm 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.
A total of 26 patients will receive 20 μg of MM-120 administered orally twice weekly for 6 weeks.
Outcomes
Primary Outcome Measures
Change in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Symptoms
Mean change from baseline in Attention-Deficit/Hyperactivity Disorder (ADHD) Symptoms
Secondary Outcome Measures
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.
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)
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)
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05200936
Brief Title
Safety and Efficacy of Low Dose MM-120 for ADHD Proof of Concept 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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 17, 2021 (Actual)
Primary Completion Date
November 10, 2023 (Anticipated)
Study Completion Date
December 8, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mind Medicine, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD, Attention Deficit Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1- Placebo
Arm Type
Placebo Comparator
Arm 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.
Arm Title
Arm 2- MM-120
Arm Type
Experimental
Arm Description
A total of 26 patients will receive 20 μg of MM-120 administered orally twice weekly for 6 weeks.
Intervention Type
Drug
Intervention Name(s)
MM-120
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
A treatment which is designed to have no therapeutic value.
Primary Outcome Measure Information:
Title
Change in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Symptoms
Description
Mean change from baseline in Attention-Deficit/Hyperactivity Disorder (ADHD) Symptoms
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Changes in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Symptoms
Description
Change from baseline in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) after 1 week (2 doses) of treatment.
Time Frame
6 weeks
Title
Number of patients who experience a decrease in the Clinical Global Impressions Scale (CGI-S)
Description
Occurrence of patients who experience at least a 1-point decrease in the Clinical Global Impressions Scale (CGI-S)
Time Frame
6 weeks
Title
Changes in patient self-assessment of Adult attention-Deficit/Hyperactivity Disorder (ADHD) symptoms
Description
Change from baseline in patient self-assessment by the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS)
Time Frame
6 weeks
Title
Changes in patient self-assessment of Adult Attention-Deficit/Hyperactivity Disorder(ADHD) symptoms
Description
Change from baseline in patient self-assessment by the Connors' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (CAARS).
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Psychological and/or clinical adverse events.
Time Frame
10 weeks
Title
Pharmacokinetic Outcomes
Description
Maximum Plasma Concentration [Cmax] of MM-120 in the blood.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mind Medicine
Phone
+1 (332) 282-0479
Email
mmed007@mindmed.co
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim Kuypers
Organizational Affiliation
Maastricht University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matthias Liechti
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University
City
Maastricht
Country
Netherlands
Individual Site Status
Completed
Facility Name
University Hospital Basel
City
Basel
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joyce Santos de Jesus
Phone
+41 61 556 5602
Email
joyce.santos@usb.ch
12. IPD Sharing Statement
Plan to Share IPD
No
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Safety and Efficacy of Low Dose MM-120 for ADHD Proof of Concept Trial
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