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

LSD

Brief Summary

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).

Intervention / Treatment

  • MM-120 (LSD D-Tartrate) (DRUG)
    A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).
  • Placebo (OTHER)
    A substance that is designed to have no therapeutic value.

Condition or Disease

  • Anxiety Generalized

Phase

  • Phase 2

    • Study Design

    Study type: INTERVENTIONAL
    Status: Active, not recruiting
    Study results: No Results Available
    Age: 18 Years to 74 Years
    Enrollment: 200 (ESTIMATED)
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Aug 27, 2022 ACTUAL
    Primary Completion: Sep 01, 2023 ACTUAL
    Completion Date: Nov 30, 2023 ESTIMATED
    Study First Posted: Jun 07, 2022 ACTUAL
    Last Updated: Sep 13, 2023

    Sponsors / Collaborators

    Lead Sponsor: N/A
    Lead sponsor is responsible party
    Responsible Party: N/A

    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).

    Participant Groups

    • A substance that is designed to have no therapeutic value.

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

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

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

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

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 74
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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)

    Primary Outcomes

    • To determine the dose-response signal and assess the dose-response relationship of 4 doses of MM-120 (25, 50, 100 or 200 μg free base equivalent) as measured by the change in HAM-A Total Score from Baseline to Week 4

    Secondary Outcomes

    • To determine the dose-response signal and assess the dose-response relationship of 4 doses of MM-120 (25, 50, 100 or 200 μg free base equivalent) as measured by the change in HAM-A Total Score from Baseline to Week 8

    • To determine the dose-response signal and assess the dose-response relationship of 4 doses of MM-120 (25, 50, 100 or 200 μg free base equivalent) as measured by the change in HAM-A Total Score from Baseline to End of Study

    • To determine whether MM-120 (25, 50, 100 or 200 μg free base equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms

    • Subjects will be assessed for safety and tolerability throughout the study by monitoring the type, frequency, and severity of AEs and SAEs

    More Details

    NCT Number: NCT05407064
    Other IDs: MMED008
    Study URL: https://clinicaltrials.gov/study/NCT05407064
    Last updated: Sep 29, 2023