search
Back to results

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

Primary Purpose

Anxiety Generalized

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MM-120 (LSD D-Tartrate)
Placebo
Sponsored by
Mind Medicine, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Generalized

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept 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) or known first-degree relative (i.e., mother/father/full siblings) with a lifetime diagnosis of schizophrenia spectrum, posttraumatic stress disorder 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)

Sites / Locations

  • Preferred Research Partners
  • Irvine Center for Clinical Research
  • Kadima Neuropsychiatry Institute
  • Pacific Neuroscience Institute
  • Mountain View Clinical Research
  • Wholeness Center
  • Segal Trials
  • CNS Healthcare - Orlando
  • iResearch Atlanta
  • Great Lakes Clinical Trials
  • Uptown Research
  • Sunstone Therapies
  • SISU BHR
  • Hassman Research Institute
  • GMI - Princeton Medical Institute
  • Nautilus Sanctuary
  • Lutheran Hospital - Cleveland Clinic
  • BioBehavioral Research of Austin
  • University of Texas Health Houston
  • Cedar Clinical Research
  • Murray
  • Woodstock Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm 1- Placebo

Arm 2- 25 μg MM-120 (LSD D-Tartrate)

Arm 3- 50 μg MM-120 (LSD D-Tartrate)

Arm 4- 100 μg MM-120 (LSD D-Tartrate)

Arm 5- 200 μg MM-120 (LSD D-Tartrate)

Arm Description

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).

Outcomes

Primary Outcome Measures

Dose-Response
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

Dose-Response
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
Dose-Response
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
Improved Quality of Life as measured by EuroQol 5 Dimension 5 Level (EQ-5D-5L)
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
Assess the incidence of Adverse Events (AEs) and Serious Adverse Events (AEs)
Subjects will be assessed for safety and tolerability throughout the study by monitoring the type, frequency, and severity of AEs and SAEs

Full Information

First Posted
May 27, 2022
Last Updated
September 13, 2023
Sponsor
Mind Medicine, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05407064
Brief Title
A Dose-Finding Study of MM-120 (LSD D-Tartrate) for the Treatment of Anxiety Symptoms
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 27, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Actual)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mind Medicine, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Generalized

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1- Placebo
Arm Type
Placebo Comparator
Arm Description
A substance that is designed to have no therapeutic value.
Arm Title
Arm 2- 25 μg MM-120 (LSD D-Tartrate)
Arm Type
Experimental
Arm Description
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).
Arm Title
Arm 3- 50 μg MM-120 (LSD D-Tartrate)
Arm Type
Experimental
Arm Description
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).
Arm Title
Arm 4- 100 μg MM-120 (LSD D-Tartrate)
Arm Type
Experimental
Arm Description
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).
Arm Title
Arm 5- 200 μg MM-120 (LSD D-Tartrate)
Arm Type
Experimental
Arm Description
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).
Intervention Type
Drug
Intervention Name(s)
MM-120 (LSD D-Tartrate)
Intervention Description
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
A substance that is designed to have no therapeutic value.
Primary Outcome Measure Information:
Title
Dose-Response
Description
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
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Dose-Response
Description
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
Time Frame
8 weeks
Title
Dose-Response
Description
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
Time Frame
12 weeks
Title
Improved Quality of Life as measured by EuroQol 5 Dimension 5 Level (EQ-5D-5L)
Description
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
Time Frame
12 weeks
Title
Assess the incidence of Adverse Events (AEs) and Serious Adverse Events (AEs)
Description
Subjects will be assessed for safety and tolerability throughout the study by monitoring the type, frequency, and severity of AEs and SAEs
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
Preferred Research Partners
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Irvine Center for Clinical Research
City
Irvine
State/Province
California
ZIP/Postal Code
92614
Country
United States
Facility Name
Kadima Neuropsychiatry Institute
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Pacific Neuroscience Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Mountain View Clinical Research
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Wholeness Center
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80525
Country
United States
Facility Name
Segal Trials
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
CNS Healthcare - Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
iResearch Atlanta
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Great Lakes Clinical Trials
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Uptown Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Sunstone Therapies
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
SISU BHR
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01103
Country
United States
Facility Name
Hassman Research Institute
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
GMI - Princeton Medical Institute
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
Nautilus Sanctuary
City
New York
State/Province
New York
ZIP/Postal Code
10012
Country
United States
Facility Name
Lutheran Hospital - Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44113
Country
United States
Facility Name
BioBehavioral Research of Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
University of Texas Health Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Cedar Clinical Research
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Facility Name
Murray
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Woodstock Research Center
City
Woodstock
State/Province
Vermont
ZIP/Postal Code
05091
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs