Phase 2 N=198 Randomized Quadruple-blind Treatment

A Dose-Finding Study of MM120 (LSD D-Tartrate) for the Treatment of Anxiety Symptoms

Anxiety Generalized

Bottom Line

View on ClinicalTrials.gov: NCT05407064 ↗

Enrolled (actual)

198

Serious AEs

0.5%

Results posted

Mar 2025

Primary outcome: Primary: Dose Response — -14.23; -15.35; -16.05; -19.22 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: MM120 (Drug); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Definium Therapeutics US, Inc.
Primary completion: Oct 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Dose Response	-15.51; -16.24; -16.90; -18.39; -20.94; 0.0	—
SECONDARY Dose Response	-15.51; -16.24; -16.90; -18.39; -20.94; 0.0	—
SECONDARY Change From Baseline in HAM-A Total Score	-13.6; -17.2; -14.8; -20.9; -19.7	0.1157
SECONDARY Change From Baseline in HAM-A Total Scores	-14.3; -18.7; -17.3; -21.1; -22.0	0.1006
SECONDARY Change From Baseline in HAM-A Total Scores	-14.3; -18.7; -17.3; -21.1; -22.0	0.1006
SECONDARY Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores	-12.3; -13.9; -14.6; -18.7; -19.9	0.5647
SECONDARY Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores	-12.3; -13.9; -14.6; -18.7; -19.9	0.5647
SECONDARY Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores	-12.3; -13.9; -14.6; -18.7; -19.9	0.5647
SECONDARY Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores	-12.3; -13.9; -14.6; -18.7; -19.9	0.5647
SECONDARY Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores	-12.3; -13.9; -14.6; -18.7; -19.9	0.5647
SECONDARY Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Scores	-1.4; -1.8; -2.1; -2.6; -2.5; 0	0.3330
SECONDARY Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Scores	-1.4; -1.8; -2.1; -2.6; -2.5; 0	0.3330
SECONDARY Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Scores	-1.4; -1.8; -2.1; -2.6; -2.5; 0	0.3330
SECONDARY Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Scores	-1.4; -1.8; -2.1; -2.6; -2.5; 0	0.3330
SECONDARY Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Scores	-1.4; -1.8; -2.1; -2.6; -2.5; 0	0.3330
SECONDARY Mean Clinical Global Impression - Improvement (CGI-I) Total Scores	2.7; 2.3; 2.2; 1.6; 1.9; 0	0.1889
SECONDARY Mean Clinical Global Impression - Improvement (CGI-I) Total Scores	2.7; 2.3; 2.2; 1.6; 1.9; 0	0.1889
SECONDARY Mean Clinical Global Impression - Improvement (CGI-I) Total Scores	2.7; 2.3; 2.2; 1.6; 1.9; 0	0.1889
SECONDARY Mean Clinical Global Impression - Improvement (CGI-I) Total Scores	2.7; 2.3; 2.2; 1.6; 1.9; 0	0.1889
SECONDARY Mean Clinical Global Impression - Improvement (CGI-I) Total Scores	2.7; 2.3; 2.2; 1.6; 1.9; 0	0.1889
SECONDARY Change From Baseline in Patient Global Impression - Severity (PGI-S) Total Scores	-1.1; -1.4; -1.4; -1.5; -1.5; 0	0.2450
SECONDARY Change From Baseline in Patient Global Impression - Severity (PGI-S) Total Scores	-1.1; -1.4; -1.4; -1.5; -1.5; 0	0.2450
SECONDARY Change From Baseline in Patient Global Impression - Severity (PGI-S) Total Scores	-1.1; -1.4; -1.4; -1.5; -1.5; 0	0.2450
SECONDARY Change From Baseline in Patient Global Impression - Severity (PGI-S) Total Scores	-1.1; -1.4; -1.4; -1.5; -1.5; 0	0.2450
SECONDARY Change From Baseline in Patient Global Impression - Severity (PGI-S) Total Scores	-1.1; -1.4; -1.4; -1.5; -1.5; 0	0.2450
SECONDARY Mean Patient Global Impression - Change (PGI-C) Total Scores	2.1; 1.7; 2.0; 1.5; 1.8; 0	0.0534
SECONDARY Mean Patient Global Impression - Change (PGI-C) Total Scores	2.1; 1.7; 2.0; 1.5; 1.8; 0	0.0534
SECONDARY Mean Patient Global Impression - Change (PGI-C) Total Scores	2.1; 1.7; 2.0; 1.5; 1.8; 0	0.0534
SECONDARY Mean Patient Global Impression - Change (PGI-C) Total Scores	2.1; 1.7; 2.0; 1.5; 1.8; 0	0.0534
SECONDARY Change From Baseline in Patient Global Impression - Change (PGI-C) Total Scores	2.2; 1.8; 1.8; 1.5; 1.7; 0	0.1248
SECONDARY Change From Baseline in Sheehan Disability Scale (SDS) Total Scores	-8.2; -10.8; -9.0; -15.1; -13.1; 0	—
SECONDARY Change From Baseline in Sheehan Disability Scale (SDS) Total Scores	-8.2; -10.8; -9.0; -15.1; -13.1; 0	—
SECONDARY Change From Baseline in Sheehan Disability Scale (SDS) Total Scores	-8.2; -10.8; -9.0; -15.1; -13.1; 0	—
SECONDARY Change From Baseline in Sheehan Disability Scale (SDS) Total Scores	-8.2; -10.8; -9.0; -15.1; -13.1; 0	—
SECONDARY Change From Baseline in Sheehan Disability Scale (SDS) Total Scores	-8.2; -10.8; -9.0; -15.1; -13.1; 0	—
SECONDARY Improved Quality of Life as Measured by EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS)	11.7; 17.0; 13.2; 17.7; 17.3; 0	—
SECONDARY Improved Quality of Life as Measured by EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS)	11.7; 17.0; 13.2; 17.7; 17.3; 0	—
SECONDARY Improved Quality of Life as Measured by EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS)	11.7; 17.0; 13.2; 17.7; 17.3; 0	—
SECONDARY Improved Quality of Life as Measured by EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS)	11.7; 17.0; 13.2; 17.7; 17.3; 0	—
SECONDARY Improved Quality of Life as Measured by EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS)	11.7; 17.0; 13.2; 17.7; 17.3; 0	—
SECONDARY Improved Sleep as Measured by Pittsburgh Sleep Quality Index (PSQI)	-4.3; -5.5; -4.8; -5.9; -4.9; 0	—
SECONDARY Improved Sleep as Measured by Pittsburgh Sleep Quality Index (PSQI)	-4.3; -5.5; -4.8; -5.9; -4.9; 0	—
SECONDARY Improved Sleep as Measured by Pittsburgh Sleep Quality Index (PSQI)	-4.3; -5.5; -4.8; -5.9; -4.9; 0	—
SECONDARY Improved Sexual Functioning as Measured by Arizona Sexual Experiences Questionnaire (ASEX) - Females	-3.9; -2.7; -1.3; -2.8; -2.7; 0	—
SECONDARY Improved Sexual Functioning as Measured by Arizona Sexual Experiences Questionnaire (ASEX) - Females	-3.9; -2.7; -1.3; -2.8; -2.7; 0	—
SECONDARY Improved Sexual Functioning as Measured by Arizona Sexual Experiences Questionnaire (ASEX) - Females	-3.9; -2.7; -1.3; -2.8; -2.7; 0	—
SECONDARY Improved Sexual Functioning as Measured by Arizona Sexual Experiences Questionnaire (ASEX) - Females	-3.9; -2.7; -1.3; -2.8; -2.7; 0	—
SECONDARY Improved Sexual Functioning as Measured by Arizona Sexual Experiences Questionnaire (ASEX) - Females	-3.9; -2.7; -1.3; -2.8; -2.7; 0	—
SECONDARY Improved Sexual Functioning as Measured by Arizona Sexual Experiences Questionnaire (ASEX) - Males	-0.3; -1.3; -2.4; -1.9; -2.5; 0	—
SECONDARY Improved Sexual Functioning as Measured by Arizona Sexual Experiences Questionnaire (ASEX) - Males	-0.3; -1.3; -2.4; -1.9; -2.5; 0	—
SECONDARY Improved Sexual Functioning as Measured by Arizona Sexual Experiences Questionnaire (ASEX) - Males	-0.3; -1.3; -2.4; -1.9; -2.5; 0	—
SECONDARY Improved Sexual Functioning as Measured by Arizona Sexual Experiences Questionnaire (ASEX) - Males	-0.3; -1.3; -2.4; -1.9; -2.5; 0	—
SECONDARY Improved Sexual Functioning as Measured by Arizona Sexual Experiences Questionnaire (ASEX) - Males	-0.3; -1.3; -2.4; -1.9; -2.5; 0	—
SECONDARY Summary of Sexual Dysfunction Rates (ASEX), Females, to Week 1	12; 10; 9; 6; 8; 11	—
SECONDARY Summary of Sexual Dysfunction Rates (ASEX), Females, to Week 2	14; 7; 14; 5; 10; 11	—
SECONDARY Summary of Sexual Dysfunction Rates (ASEX), Females, to Week 4	8; 6; 11; 6; 10; 13	—
SECONDARY Summary of Sexual Dysfunction Rates (ASEX), Females, to Week 8	5; 6; 11; 6; 8; 14	—
SECONDARY Summary of Sexual Dysfunction Rates (ASEX), Females, to Week 12	6; 4; 10; 6; 7; 12	—
SECONDARY Summary of Sexual Dysfunction Rates (ASEX), Males, to Week 1	1; 4; 3; 2; 3; 9	—
SECONDARY Summary of Sexual Dysfunction Rates (ASEX), Males, to Week 2	0; 3; 3; 2; 1; 11	—
SECONDARY Summary of Sexual Dysfunction Rates (ASEX), Males, to Week 4	0; 3; 4; 1; 0; 10	—
SECONDARY Summary of Sexual Dysfunction Rates (ASEX), Males, to Week 8	1; 3; 4; 1; 1; 7	—
SECONDARY Summary of Sexual Dysfunction Rates (ASEX), Males, to Week 12	1; 3; 1; 2; 0; 7	—

Summary

This is a Phase 2, multi-center, randomized, double-blind, parallel-group, dose-finding study to assess the effect of 4 doses of MM120 (25, 50, 100 or 200 μg freebase-equivalent) for the treatment of anxiety symptoms in subjects diagnosed with generalized anxiety disorder (GAD).

Eligibility Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05407064). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.