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NCT05407064PHASE2COMPLETED

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

Sponsor: Definium Therapeutics US, Inc.

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Key Facts

Study type
INTERVENTIONAL
Conditions
Anxiety Generalized
Interventions
MM120, Placebo
Enrollment
198 participants
Primary completion
Oct 2023
Study completion
Nov 2023
First posted
Jun 2022
Last updated
Feb 2026

Primary Endpoints (CT.gov)

Dose Response

Time frame: 4 weeks

Secondary Endpoints

Dose Response

Change From Baseline in HAM-A Total Score

Change From Baseline in HAM-A Total Scores

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 spe

Read full criteria on CT.gov →

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov