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

Anxiety Generalized Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05407064
• Other study ID #: MMED008
• Status: Completed
• Phase: Phase 2
• Start date: August 24, 2022
• Est. completion date: November 27, 2023

Study information

• Verified date: December 2023
• Source: Mind Medicine, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: November 27, 2023
• Est. primary completion date: October 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety Generalized

Intervention

Drug:
• MM-120 (LSD D-Tartrate)
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).

Other:
• Placebo
A substance that is designed to have no therapeutic value.

Locations

Country	Name	City	State
United States	BioBehavioral Research of Austin	Austin	Texas
United States	Hassman Research Institute	Berlin	New Jersey
United States	Great Lakes Clinical Trials	Chicago	Illinois
United States	Uptown Research	Chicago	Illinois
United States	Lutheran Hospital - Cleveland Clinic	Cleveland	Ohio
United States	iResearch Atlanta	Decatur	Georgia
United States	Mountain View Clinical Research	Denver	Colorado
United States	Cedar Clinical Research	Draper	Utah
United States	Wholeness Center	Fort Collins	Colorado
United States	University of Texas Health Houston	Houston	Texas
United States	Irvine Center for Clinical Research	Irvine	California
United States	Kadima Neuropsychiatry Institute	La Jolla	California
United States	Segal Trials	Lauderhill	Florida
United States	Preferred Research Partners	Little Rock	Arkansas
United States	Cedar Clinical Research - Murray	Murray	Utah
United States	CNS Healthcare - Orlando	Orlando	Florida
United States	GMI - Princeton Medical Institute	Princeton	New Jersey
United States	Sunstone Therapies	Rockville	Maryland
United States	Pacific Neuroscience Institute	Santa Monica	California
United States	Woodstock Research Center	Woodstock	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
Mind Medicine, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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