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

Phase 2

Completed

• Conditions: Anxiety Generalized
• Interventions: Other: Placebo; Drug: MM-120 (LSD D-Tartrate)

• Registration Number: NCT05407064
• Lead Sponsor: Mind Medicine, Inc.

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2022-05-27
• Study First Submitted QC: 2022-06-01
• Study First Posted: 2022-06-07
• Study Start: 2022-08-24
• Primary Completion: 2023-10-06
• Study Completion: 2023-11-27
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1- Placebo	Placebo	A substance that is designed to have no therapeutic value.
Arm 3- 50 μg MM-120 (LSD D-Tartrate)	MM-120 (LSD D-Tartrate)	A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).
Arm 4- 100 μg MM-120 (LSD D-Tartrate)	MM-120 (LSD D-Tartrate)	A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).
Arm 2- 25 μg MM-120 (LSD D-Tartrate)	MM-120 (LSD D-Tartrate)	A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).
Arm 5- 200 μg MM-120 (LSD D-Tartrate)	MM-120 (LSD D-Tartrate)	A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).

Primary Outcome Measures

Name	Time	Method
Dose-Response	4 weeks	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

Secondary Outcome Measures

Name	Time	Method
Improved Quality of Life as measured by EuroQol 5 Dimension 5 Level (EQ-5D-5L)	12 weeks	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
Dose-Response	12 weeks	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
Assess the incidence of Adverse Events (AEs) and Serious Adverse Events (AEs)	12 weeks	Subjects will be assessed for safety and tolerability throughout the study by monitoring the type, frequency, and severity of AEs and SAEs

Trial Locations

Locations (20)

Irvine Center for Clinical Research; 🇺🇸 Irvine, California, United States

Lutheran Hospital - Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

iResearch Atlanta; 🇺🇸 Decatur, Georgia, United States

Great Lakes Clinical Trials; 🇺🇸 Chicago, Illinois, United States

Segal Trials; 🇺🇸 Lauderhill, Florida, United States

Cedar Clinical Research; 🇺🇸 Draper, Utah, United States

Sunstone Therapies; 🇺🇸 Rockville, Maryland, United States

Cedar Clinical Research - Murray; 🇺🇸 Murray, Utah, United States

GMI - Princeton Medical Institute; 🇺🇸 Princeton, New Jersey, United States

Hassman Research Institute; 🇺🇸 Berlin, New Jersey, United States

Pacific Neuroscience Institute; 🇺🇸 Santa Monica, California, United States

Kadima Neuropsychiatry Institute; 🇺🇸 La Jolla, California, United States

Uptown Research; 🇺🇸 Chicago, Illinois, United States

University of Texas Health Houston; 🇺🇸 Houston, Texas, United States

Wholeness Center; 🇺🇸 Fort Collins, Colorado, United States

Mountain View Clinical Research; 🇺🇸 Denver, Colorado, United States

Woodstock Research Center; 🇺🇸 Woodstock, Vermont, United States

Preferred Research Partners; 🇺🇸 Little Rock, Arkansas, United States

CNS Healthcare - Orlando; 🇺🇸 Orlando, Florida, United States

BioBehavioral Research of Austin; 🇺🇸 Austin, Texas, United States