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

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ClinicalTrials.gov Identifier: NCT05407064
Recruitment Status : Completed
First Posted : June 7, 2022
Last Update Posted : December 20, 2023
Sponsor:
Information provided by (Responsible Party):
Mind Medicine, Inc.

Study Description
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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).

Condition or disease Intervention/treatment Phase
Anxiety Generalized Drug: MM-120 (LSD D-Tartrate) Other: Placebo Phase 2

Detailed 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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multi-center, Randomized, Double-Blind, Parallel-Group, Dose-Finding Study to Assess the Effect of Four Doses of MM-120 (LSD D-Tartrate) for the Treatment of Anxiety Symptoms
Actual Study Start Date : August 24, 2022
Actual Primary Completion Date : October 6, 2023
Actual Study Completion Date : November 27, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Arm 1- Placebo
A substance that is designed to have no therapeutic value.
 Other: Placebo
A substance that is designed to have no therapeutic value.
Experimental: Arm 2- 25 μg MM-120 (LSD D-Tartrate)
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).
 Drug: MM-120 (LSD D-Tartrate)
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).
Experimental: Arm 3- 50 μg MM-120 (LSD D-Tartrate)
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).
 Drug: MM-120 (LSD D-Tartrate)
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).
Experimental: Arm 4- 100 μg MM-120 (LSD D-Tartrate)
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).
 Drug: MM-120 (LSD D-Tartrate)
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).
Experimental: Arm 5- 200 μg MM-120 (LSD D-Tartrate)
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).
 Drug: MM-120 (LSD D-Tartrate)
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).


Outcome Measures
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Primary Outcome Measures :
  1. Dose-Response [ Time Frame: 4 weeks ]
    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 Outcome Measures :
  1. Dose-Response [ Time Frame: 8 weeks ]
    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

  2. Dose-Response [ Time Frame: 12 weeks ]
    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

  3. Improved Quality of Life as measured by EuroQol 5 Dimension 5 Level (EQ-5D-5L) [ Time Frame: 12 weeks ]
    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

  4. Assess the incidence of Adverse Events (AEs) and Serious Adverse Events (AEs) [ Time Frame: 12 weeks ]
    Subjects will be assessed for safety and tolerability throughout the study by monitoring the type, frequency, and severity of AEs and SAEs


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05407064


Locations
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Sponsors and Collaborators
Mind Medicine, Inc.
More Information
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Responsible Party: Mind Medicine, Inc.
ClinicalTrials.gov Identifier: NCT05407064    
Other Study ID Numbers: MMED008
First Posted: June 7, 2022    Key Record Dates
Last Update Posted: December 20, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders