Safety and Efficacy of Low Dose MM-120 for ADHD Proof of Concept Trial
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 |
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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
Arms and Interventions
Arm | Intervention/Treatment |
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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.
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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.
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Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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)
- 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)
- 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
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [10 weeks]
Psychological and/or clinical adverse events.
- Pharmacokinetic Outcomes [6 weeks]
Maximum Plasma Concentration [Cmax] of MM-120 in the blood.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male and female outpatients ≥ 18 and ≤ 65 years of age at Screening
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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).
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Adequate organ function.
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Able to understand the study procedures and understand risks associated with the study, and sign written informed consent to participate in the study.
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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:
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Past or present diagnosis of a primary psychotic disorder or first degree relative with a psychotic disorder.
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Past or present bipolar disorder (DSM-5).
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Any lifetime history of suicide attempt.
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Once Informed Consent form is signed, not willing or able to stop any prescription or non-prescription ADHD medications.
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Use of investigational medication/treatment in the past 30 days.
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Patients with a positive urine drug screen with the exception of THC or its metabolites.
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Pregnant or nursing females.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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.- MMED007