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

NCT06741228 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: MM120-300
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 34

Brief Summary

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

Conditions

Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (23)

• Change from Baseline in HAM-A total score at Week 8, Week 4, Week 2, and Week 1

  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

  Baseline to Week 12

• HAM-A remission (total score ≤7) at each timepoint assessed during the 12-week double-blind treatment period

  Baseline to Week 12

• Clinical Global Impression - Improvement (CGI-I) Scale score at each timepoint assessed during the 12-week double-blind period

  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

  Baseline to Week 12

Study Arms (2)

Arm 1 - Placebo

PLACEBO COMPARATOR

A substance that is designed to have no therapeutic value

Other: Placebo

Arm 2 - 100µg MM120 (LSD D-Tartrate)

EXPERIMENTAL

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

Drug: MM120 (LSD D-Tartrate)

Interventions

Placebo OTHER

A substance that is designed to have no therapeutic value

Arm 1 - Placebo

MM120 (LSD D-Tartrate) DRUG

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

Arm 2 - 100µg MM120 (LSD D-Tartrate)

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Definium Therapeutics US, Inc.: lead

Study Sites (34)

Lighthouse Psychiatry

Gilbert, Arizona, 85234, United States

Location

Scottsdale Research Institute

Scottsdale, Arizona, 85022, United States

Location

Kadima Neuropsychiatry Institute

La Jolla, California, 92037, United States

Location

UCSF Department of Neurology

San Francisco, California, 94158, United States

Location

Psychedelic Science Institute

Santa Monica, California, 90404, United States

Location

Mountain View

Denver, Colorado, 80209, United States

Location

Clinical Neuroscience Solutions Inc.

Jacksonville, Florida, 32256, United States

Location

Segal Trials

Lauderhill, Florida, 33319, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

iResearch Atlanta

Decatur, Georgia, 30030, United States

Location

CenExel iResearch, LLC

Savannah, Georgia, 31405, United States

Location

Uptown Research Institute

Chicago, Illinois, 60640, United States

Location

Adams Clinical Boston

Boston, Massachusetts, 02116, United States

Location

Adams Clinical Watertown

Watertown, Massachusetts, 02472, United States

Location

Hassman Research Institute

Marlton, New Jersey, 08053, United States

Location

Spectrum Neuroscience and Treatment Institute

New York, New York, 10021, United States

Location

Adams Clinical Harlem

New York, New York, 10029, United States

Location

New York State Psychiatric Institute (NYSPI)

New York, New York, 10032, United States

Location

Adams Clinical Bronx

The Bronx, New York, 10461, United States

Location

Cleveland Clinic Lutheran Hospital

Cleveland, Ohio, 44113, United States

Location

Summit Headlands LLC

Portland, Oregon, 97210, United States

Location

Scranton Medical Institute

Moosic, Pennsylvania, 18507, United States

Location

Adams Clinical Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

Location

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, 38119, United States

Location

University of Texas at Austin

Austin, Texas, 78712, United States

Location

Austin Clinical Trial Partners

Austin, Texas, 78737, United States

Location

BioBehavioral Research of Austin

Austin, Texas, 78759, United States

Location

FutureSearch Trials of Dallas, LLC

Dallas, Texas, 75231, United States

Location

Adams Clinical Dallas

DeSoto, Texas, 75115, United States

Location

Cedar Clinical Research

Draper, Utah, 84020, United States

Location

Inner Space Research

Orem, Utah, 84058, United States

Location

Memory Clinic Inc.

Bennington, Vermont, 05201, United States

Location

Seattle Neuropsychiatric Treatment Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study is double-blinded, which means that both the participants and the treating clinicians will be masked to treatment allocation, meaning neither party will know which participants are receiving the active drug and which are receiving the placebo. The placebo tablet is identical looking to the active drug
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 18, 2024
• Study Start: December 11, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2025-05

Locations

US (34)