A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (Voyage) (Voyage)

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, 12-Week Study (Part A) With a 40-Week Open-label Extension (Part B) Evaluating the Efficacy and Safety of Oral MM120 Compared to Placebo in the Treatment of Adults With Generalized Anxiety Disorder - Voyage

A Phase 3 Double-blind, Placebo-controlled Study (Part A) with an Open-label Extension (Part B) Evaluating MM120 Compared to Placebo in Generalized Anxiety Disorder - Voyage

Study Overview

• Status: Active, not recruiting
• Conditions: Generalized Anxiety Disorder
• Intervention / Treatment: Other: Placebo; Drug: MM120 (LSD D-Tartrate)

Detailed Description

The study will enroll up to 200 participants aged 18 to 74 years, inclusive with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) confirmed primary diagnosis of GAD and a minimum HAM-A total score of at least 20 at Screening and Baseline without clinically relevant medical or psychiatric history.

The study consists of a 12-week randomized, double-blind, single-dose administration period evaluating MM120 versus placebo, followed by a 40-week extension phase with the opportunity for open-label treatment. During this phase, participants will be monitored and evaluated for potential treatment with MM120 based on pre-specified safety and symptom severity criteria.

• Study Type: Interventional
• Enrollment (Actual): 214
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • Lighthouse Psychiatry
    • Scottsdale, Arizona, United States, 85022
      • Scottsdale Research Institute
  • California
    • La Jolla, California, United States, 92037
      • Kadima Neuropsychiatry Institute
    • San Francisco, California, United States, 94158
      • UCSF Department of Neurology
    • Santa Monica, California, United States, 90404
      • Psychedelic Science Institute
  • Colorado
    • Denver, Colorado, United States, 80209
      • Mountain View
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Clinical Neuroscience Solutions Inc.
    • Lauderhill, Florida, United States, 33319
      • Segal Trials
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Atlanta Center for Medical Research
    • Decatur, Georgia, United States, 30030
      • iResearch Atlanta
    • Savannah, Georgia, United States, 31405
      • CenExel iResearch, LLC
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Uptown Research Institute
  • Massachusetts
    • Boston, Massachusetts, United States, 02116
      • Adams Clinical Boston
    • Watertown, Massachusetts, United States, 02472
      • Adams Clinical Watertown
  • New Jersey
    • Marlton, New Jersey, United States, 08053
      • Hassman Research Institute
  • New York
    • New York, New York, United States, 10021
      • Spectrum Neuroscience and Treatment Institute
    • New York, New York, United States, 10032
      • New York State Psychiatric Institute (NYSPI)
    • New York, New York, United States, 10029
      • Adams Clinical Harlem
    • The Bronx, New York, United States, 10461
      • Adams Clinical Bronx
  • Ohio
    • Cleveland, Ohio, United States, 44113
      • Cleveland Clinic Lutheran Hospital
  • Oregon
    • Portland, Oregon, United States, 97210
      • Summit Headlands LLC
  • Pennsylvania
    • Moosic, Pennsylvania, United States, 18507
      • Scranton Medical Institute
    • Philadelphia, Pennsylvania, United States, 19104
      • Adams Clinical Philadelphia
  • South Carolina
    • North Charleston, South Carolina, United States, 29405
      • Coastal Carolina Research Center
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutions, Inc.
  • Texas
    • Austin, Texas, United States, 78712
      • University of Texas at Austin
    • Austin, Texas, United States, 78759
      • BioBehavioral Research of Austin
    • Austin, Texas, United States, 78737
      • Austin Clinical Trial Partners
    • Dallas, Texas, United States, 75231
      • FutureSearch Trials of Dallas, LLC
    • DeSoto, Texas, United States, 75115
      • Adams Clinical Dallas
  • Utah
    • Draper, Utah, United States, 84020
      • Cedar Clinical Research
    • Orem, Utah, United States, 84058
      • Inner Space Research
  • Vermont
    • Bennington, Vermont, United States, 05201
      • Memory Clinic Inc.
  • Washington
    • Seattle, Washington, United States, 98104
      • Seattle Neuropsychiatric Treatment Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Diagnosis of GAD per DSM-5
2. Male or female aged 18 to 74
3. HAM-A Total Score ≥20

Exclusion Criteria:

1. Certain psychiatric disorders (other than generalized anxiety disorder)
2. First degree relative with or lifetime history of a psychotic disorder or bipolar disorder
3. Current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine)
4. Any clinically significant unstable illness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 - 100µg MM120 (LSD D-Tartrate); A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)	Drug: MM120 (LSD D-Tartrate); A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at Week 12	The HAM-A consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.	Baseline to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in HAM-A total score at Week 8, Week 4, Week 2, and Week 1	The HAM-A consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.	Week 8, Week 4, Week 2, and Week 1
HAM-A response (reduction from Baseline score of ≥50%) at each timepoint assessed during the 12-week double-blind period	The HAM-A consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.	Baseline to Week 12
HAM-A remission (total score ≤7) at each timepoint assessed during the 12-week double-blind treatment period	The HAM-A consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.	Baseline to Week 12
Clinical Global Impression - Improvement (CGI-I) Scale score at each timepoint assessed during the 12-week double-blind period	The CGI-I scale is used to measure the clinician's assessment of how much the participant's illness has improved or worsened relative to Baseline (Visit 2). The CGI-I comprises one item with 7 possible ratings (1-7 points), where a lower score indicates improvement, and a higher score indicates worsening.	Day 2 to Week 12
Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in Clinical Global Impression - Severity (CGI-S) Scale score	The CGI-S scale assesses the clinician's impression of the participant's current severity of illness relative to the clinician's experience with patients who have the same diagnosis. The CGI-S comprises one item with 7 possible ratings (1-7 points), where a higher score indicates more severe illness.	Baseline to Week 12
Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in Patient Global Impression - Severity (PGI-S) Scale score	The PGI scale is the patient-reported outcome (PRO) counterpart to the CGI scale. The PGI-S comprises one participant-completed item with 5 possible ratings (1-5) where a higher score indicates more severe illness.	Baseline to Week 12
Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in -Montgomery-Åsberg Depression Rating Scale (MADRS) total score	The MADRS is used to assess depression severity and to detect changes due to antidepressant treatment. The MADRS includes 10 clinician-completed items. Each of the 10 questions is scored with a range of 0-6 points. An item score of 0 indicates item not present or normal, while an item score of 6 indicates severe or continuous presence of the symptoms. The total possible score is 60, and higher scores represent a more severe condition.	Baseline to Week 12
Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in -Work Productivity and Activity Impairment Questionnaire (WPAI)	The WPAI-SHP is a 6-item questionnaire, with a recall period of the past 7 days. The WPAI measures impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as impairment in unpaid activity because of the health problem under study.	Baseline to Week 12
Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in -EuroQol-5 Dimensions - 5 Levels (EQ-5D-5L)	The EuroQol 5 Dimension 5 Level (EQ-5D-5L) is a self-reported outcome measure used to evaluate health outcomes over a wide range of health conditions and treatments. The EQ-5D consists of the EQ-5D descriptive system and the EQ visual analogue scale (VAS).	Baseline to Week 12
Change from Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ-14) total score at each timepoint assessed during the double-blind period	The CSFQ-14 is a structured self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning that consists of 14 items measuring sexual functioning as a total score (14 items). There is a male and female version of the CSFQ-14 scale and a total score of less than 47 for men and less than 41 for women indicates sexual dysfunction. Lower scores are associated with worsened sexual functioning.	Baseline to Week 12
Percent of men and women with normal and abnormal sexual functioning at each timepoint assessed during the double-blind period	The CSFQ-14 is a structured self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning that consists of 14 items measuring sexual functioning as a total score (14 items). There is a male and female version of the CSFQ-14 scale and a total score of less than 47 for men and less than 41 for women indicates sexual dysfunction. Lower scores are associated with worsened sexual functioning.	Baseline to Week 12
Percent of participants requiring one, two, three, four, or five doses of MM120 during the 52-week study (Part A and Part B) as assessed by participants meeting protocol-specified retreatment criteria during the 40-week open-label period	Percent of participants requiring one, two, three, four, or five doses of MM120 during the 52-week study (Part A and Part B) as assessed by participants meeting protocol-specified retreatment criteria during the 40-week open-label period	Day 1 to Week 52
Time to first treatment or lack of efficacy in the open-label period (Part B)	Measured as time from first dosing in the Double-blind period to participant meeting HAM-A criteria for re-dose or meeting criteria for lack of efficacy	Day 1 to Week 52
Need for MM120 treatment as assessed by the average number of MM120 treatments during the study	Average number of treatments assessed from first dose in the double-blind period through completion of the open label extension.	Day 1 to Week 52
HAM-A response (reduction from Baseline score of ≥50%) at each timepoint assessed during the 40-week open-label period	The HAM-A consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.	40 week open label period
HAM-A remission (total score ≤7) at each timepoint assessed during the 40-week open-label period	The HAM-A consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.	40 week open label period
Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in Clinical Global Impression - Severity (CGI-S) Scale score	The CGI-S scale assesses the clinician's impression of the participant's current severity of illness relative to the clinician's experience with patients who have the same diagnosis. The CGI-S comprises one item with 7 possible ratings (1-7 points), where a higher score indicates more severe illness.	Baseline to Week 52
Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in Patient Global Impression - Severity (PGI-S) Scale score	The PGI scale is the patient-reported outcome (PRO) counterpart to the CGI scale. The PGI-S comprises one participant-completed item with 5 possible ratings (1-5) where a higher score indicates more severe illness.	Baseline to Week 52
Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in MADRS total score	The MADRS is used to assess depression severity and to detect changes due to antidepressant treatment. The MADRS includes 10 clinician-completed items. Each of the 10 questions is scored with a range of 0-6 points. An item score of 0 indicates item not present or normal, while an item score of 6 indicates severe or continuous presence of the symptoms. The total possible score is 60, and higher scores represent a more severe condition.	Baseline to Week 52
Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in WPAI	The WPAI-SHP is a 6-item questionnaire, with a recall period of the past 7 days. The WPAI measures impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as impairment in unpaid activity because of the health problem under study.	Baseline to Week 52
Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in EQ-5D-5L	The EuroQol 5 Dimension 5 Level (EQ-5D-5L) is a self-reported outcome measure used to evaluate health outcomes over a wide range of health conditions and treatments. The EQ-5D consists of the EQ-5D descriptive system and the EQ visual analogue scale (VAS).	Baseline to Week 52
CSFQ-14 total score at each timepoint assessed during the open-label period	The CSFQ-14 is a structured self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning that consists of 14 items measuring sexual functioning as a total score (14 items). There is a male and female version of the CSFQ-14 scale and a total score of less than 47 for men and less than 41 for women indicates sexual dysfunction. Lower scores are associated with worsened sexual functioning.	40 week open label period
Percent men and women with normal and abnormal sexual functioning at each timepoint assessed during the open-label period	The CSFQ-14 is a structured self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning that consists of 14 items measuring sexual functioning as a total score (14 items). There is a male and female version of the CSFQ-14 scale and a total score of less than 47 for men and less than 41 for women indicates sexual dysfunction. Lower scores are associated with worsened sexual functioning.	40 week open label period

Collaborators and Investigators

• Sponsor: Definium Therapeutics US, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: December 16, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): December 18, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Generalized Anxiety Disorder; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: MM120-300

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No