A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (Voyage)

MindMed

Status and phase: Enrolling; Phase 3

Conditions: Generalized Anxiety Disorder

Treatments: Drug: MM120 (LSD D-Tartrate); Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06741228

MM120-300

Details and patient eligibility

About

A Phase 3 Double-blind, Placebo-controlled Study (Part A) with an Open-label Extension (Part B) Evaluating MM120 Compared to Placebo in Generalized Anxiety Disorder - Voyage

Full description

The study will enroll up to 200 participants aged 18 to 74 years, inclusive with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) confirmed primary diagnosis of GAD and a minimum HAM-A total score of at least 20 at Screening and Baseline without clinically relevant medical or psychiatric history.

The study consists of a 12-week randomized, double-blind, single-dose administration period evaluating MM120 versus placebo, followed by a 40-week extension phase with the opportunity for open-label treatment. During this phase, participants will be monitored and evaluated for potential treatment with MM120 based on pre-specified safety and symptom severity criteria.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of GAD per DSM-5
2. Male or female aged 18 to 74
3. HAM-A Total Score ≥20

Exclusion criteria

1. Certain psychiatric disorders (other than generalized anxiety disorder)
2. First degree relative with or lifetime history of a psychotic disorder or bipolar disorder
3. Current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine)
4. Any clinically significant unstable illness

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups, including a placebo group

Arm 1 - Placebo

Placebo Comparator group

Description:

A substance that is designed to have no therapeutic value

Treatment:

Other: Placebo

Arm 2 - 100µg MM120 (LSD D-Tartrate)

Experimental group

Description:

A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)

Treatment:

Drug: MM120 (LSD D-Tartrate)