A Dose-Finding Study of MM-120 for the Treatment... — Clinical Trial Details

Multi-centre, randomised, quadruple-blind, parallel-group Phase II trial in approximately 198 participants with DSM-5 GAD and HAM-A ≥20 comparing placebo and four ascending single doses of MM-120 (25–200 µg, oral capsule).

Primary aim is treatment of anxiety symptoms; participants on contraindicated medications will undergo tapering prior to baseline. Safety and tolerability, and standard anxiety outcome measures (including HAM-A) will be assessed.

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
Minimum HAM-A Total Score of 20
Subjects on contraindicated concomitant medications, supplements or other therapeutics at Screening will undergo a medication taper prior to advancing to Baseline.

Women of childbearing potential 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 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) 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)

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A Dose-Finding Study of MM-120 for the Treatment of Anxiety Symptoms

Detailed Description

Study Arms & Interventions

Placebo

Interventions

MM-120 25 µg

Interventions

Locations

Related Publications

Single Treatment With MM120 (Lysergide) in Generalized Anxiety Disorder: A Randomized Clinical Trial

MM-120 50 µg

Interventions

MM-120 100 µg

Interventions

MM-120 200 µg

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

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