A Dose-Finding Study of MM-120 (LSD D-Tartrate) for the Treatment of Anxiety Symptoms

Study Overview
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Brief Summary
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This is a Phase 2, multi-center, randomized, double-blind, parallel-group, dose-finding study to assess the effect of 4 doses of MM-120 (25, 50, 100 or 200 μg freebase-equivalent) for the treatment of anxiety symptoms in subjects diagnosed with generalized anxiety disorder (GAD).

Detailed Description
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The study will enroll approximately 200 male and female subjects 18 years to < 75 years of age who meet DSM-5 criteria for GAD and have a minimum HAM-A Total Score of 20. Subjects on contraindicated concomitant medications, supplements or other therapeutics at Screening (Visit 1) will undergo a medication taper prior to advancing to Baseline (Visit 2).

Official Title
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A Phase 2, Multi-center, Randomized, Double-Blind, Parallel-Group, Dose-Finding Study to Assess the Effect of Four Doses of MM-120 (LSD D-Tartrate) for the Treatment of Anxiety Symptoms

Conditions
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Anxiety Generalized

Intervention / Treatment
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* Drug: MM-120 (LSD D-Tartrate)
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Bodyweight of ≥ 50 kg Body mass index [BMI] ≥ 18 to ≤ 38 mg/kg2 Diagnosis of DSM-5 generalized anxiety disorder Acceptable overall medical condition to be safely enrolled into and to complete the study Ability to swallow capsules Ability to provide informed consent Exclusion Criteria: Women of childbearing potential (WOCBP) (i.e., physiologically capable of becoming pregnant) who are unwilling or unable to use a highly effective method of contraception for the duration of the study, OR Men physiologically capable of fathering a child who are sexually active with WOCBP but are unwilling or unable to use barrier contraception (e.g., condom with or without spermicidal cream or jelly) for the duration of the study Women who are currently pregnant or breastfeeding or plan to become pregnant or breastfeed during the study Men who plan to donate sperm during the study Prior history (lifetime diagnosis) with a lifetime diagnosis of schizophrenia spectrum, or other psychotic disorders or bipolar disorder Has a significant risk of suicide attempt based upon medical history or has active suicidal ideation Unwillingness or inability to discontinue prohibited concomitant medications, supplements or other therapeutics (prescription or over-the-counter)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Arm 1- Placebo<br>A substance that is designed to have no therapeutic value. | Other: Placebo<br>* A substance that is designed to have no therapeutic value.<br>|
| Experimental: Arm 2- 25 μg MM-120 (LSD D-Tartrate)<br>A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A). | Drug: MM-120 (LSD D-Tartrate)<br>* A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).<br>|
| Experimental: Arm 3- 50 μg MM-120 (LSD D-Tartrate)<br>A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A). | Drug: MM-120 (LSD D-Tartrate)<br>* A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).<br>|
| Experimental: Arm 4- 100 μg MM-120 (LSD D-Tartrate)<br>A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A). | Drug: MM-120 (LSD D-Tartrate)<br>* A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).<br>|
| Experimental: Arm 5- 200 μg MM-120 (LSD D-Tartrate)<br>A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A). | Drug: MM-120 (LSD D-Tartrate)<br>* A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-Response | To determine the dose-response signal and assess the dose-response relationship of 4 doses of MM-120 (25, 50, 100 or 200 μg free base equivalent) as measured by the change in HAM-A Total Score from Baseline to Week 4 | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-Response | To determine the dose-response signal and assess the dose-response relationship of 4 doses of MM-120 (25, 50, 100 or 200 μg free base equivalent) as measured by the change in HAM-A Total Score from Baseline to Week 8 | 8 weeks | 
| Dose-Response | To determine the dose-response signal and assess the dose-response relationship of 4 doses of MM-120 (25, 50, 100 or 200 μg free base equivalent) as measured by the change in HAM-A Total Score from Baseline to End of Study | 12 weeks | 
| Improved Quality of Life as measured by EuroQol 5 Dimension 5 Level (EQ-5D-5L) | To determine whether MM-120 (25, 50, 100 or 200 μg free base equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms | 12 weeks | 
| Assess the incidence of Adverse Events (AEs) and Serious Adverse Events (AEs) | Subjects will be assessed for safety and tolerability throughout the study by monitoring the type, frequency, and severity of AEs and SAEs | 12 weeks |