A Dose-Finding Study of MM-120 (LSD D-Tartrate) for the Treatment of Anxiety Symptoms

MindMed

Status and phase: Completed; Phase 2

Conditions: Anxiety Generalized

Treatments: Drug: MM-120 (LSD D-Tartrate); Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05407064

MMED008

Details and patient eligibility

About

This is a Phase 2, multi-center, randomized, double-blind, parallel-group, dose-finding study to assess the effect of 4 doses of MM-120 (25, 50, 100 or 200 μg freebase-equivalent) for the treatment of anxiety symptoms in subjects diagnosed with generalized anxiety disorder (GAD).

Full description

The study will enroll approximately 200 male and female subjects 18 years to < 75 years of age who meet DSM-5 criteria for GAD and have a minimum HAM-A Total Score of 20. Subjects on contraindicated concomitant medications, supplements or other therapeutics at Screening (Visit 1) will undergo a medication taper prior to advancing to Baseline (Visit 2).

Enrollment: 198 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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198 participants in 5 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- 25 μg MM-120 (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: MM-120 (LSD D-Tartrate)

Arm 3- 50 μg MM-120 (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: MM-120 (LSD D-Tartrate)

Arm 4- 100 μg MM-120 (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: MM-120 (LSD D-Tartrate)

Arm 5- 200 μg MM-120 (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: MM-120 (LSD D-Tartrate)