A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (VOYAGE) (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 open-label extension (OLE) during which participants will be monitored and evaluated for potential retreatment 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. Male or female: must be between 18 (or the legal age of consent in the jurisdiction in which the study is taking place) and 74 years of age inclusive, at the time of signing the informed consent.
2. Diagnosis of GAD per DSM-5.
3. HAM-A Total Score ≥20.

Exclusion criteria

1. Any psychiatric disorder (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)