NCT05407064|CompletedPhase 2ResultsFDA Drug

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

A Phase 2, Multi-center, Randomized, Double-Blind, Parallel-Group, Dose-Finding Study to Assess the Effect of Four Doses of MM120 (LSD D-Tartrate) for the Treatment of Anxiety Symptoms

Definium Therapeutics US, Inc.ClinicalTrials.gov

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1 other identifier

MMED008

Study Type

interventional

Target

198

Locations

1 country

Sites

Timeline

RegisteredJun 2022

StartedAug 2022

CompletionNov 2023

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 MM120 (25, 50, 100 or 200 μg freebase-equivalent) for the treatment of anxiety symptoms in subjects diagnosed with generalized anxiety disorder (GAD).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

198

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Aug 2022

Shorter than P25 for phase_2

Geographic Reach

1 country

22 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

First Submitted

Initial submission to the registry

May 27, 2022

Completed

11 days until next milestone

First Posted

Study publicly available on registry

June 7, 2022

Completed

3 months until next milestone

Study Start

First participant enrolled

August 24, 2022

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2023

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2023

Completed

1.3 years until next milestone

Results Posted

Study results publicly available

March 20, 2025

Completed

Last Updated

February 27, 2026

Status Verified

September 1, 2025

Enrollment Period

1.1 years

First QC Date

May 27, 2022

Results QC Date

November 20, 2024

Last Update Submit

February 9, 2026

Conditions

Anxiety Generalized

Outcome Measures

Primary Outcomes (1)

Dose Response
To investigate the dose-response relationship for different doses of MM120 versus placebo in change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Week 4. The HAM-A consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety: Anxious mood, Tension, Fears, Insomnia, Intellectual, Depressed mood, Somatic (muscular), Somatic (sensory), Cardiovascular symptoms, Respiratory symptoms, Gastrointestinal symptoms, Genitourinary symptoms, Autonomic symptoms, and Behavior at interview (general). The central rater assessed the extent to which the subject displayed each given criterion and gave a rating on a scale of 0-4, where 4 represents the most severe symptoms. Minimum score = 0, maximum score = 56. Scores are summed and the greater the total score, the more severe illness.
4 weeks

Secondary Outcomes (62)

Dose Response
8 weeks
Change From Baseline in HAM-A Total Score
4 weeks
Change From Baseline in HAM-A Total Scores
8 weeks
Change From Baseline in HAM-A Total Scores
12 weeks
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores
Week 1
+57 more secondary outcomes

Study Arms (5)

Arm 1- Placebo

PLACEBO COMPARATOR

A substance that is designed to have no therapeutic value.

Other: Placebo