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

NCT06809595 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: MM120-301
• Study Type: interventional
• Target: 245
• Locations: 6 countries
• Sites: 37

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 - Panorama

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 (3)

Arm 1 - Placebo

PLACEBO COMPARATOR

A substance that is designed to have no therapeutic value

Other: Placebo

Arm 2 - 50µg MM120 (LSD D-Tartrate)

SHAM COMPARATOR

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

Drug: MM120 (LSD D-Tartrate)

Arm 3 - 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 - 50µg MM120 (LSD D-Tartrate); Arm 3 - 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 (37)

Preferred Research Partners, Inc.

Little Rock, Arkansas, 72211, United States

Location

Psychedelic Science Institute

Los Angeles, California, 90004, United States

Location

West Los Angeles VA Medical Center

Los Angeles, California, 90073, United States

Location

Bradenton Research Center, Inc.

Bradenton, Florida, 34205, United States

Location

Clinical Neuroscience Solutions, Inc

Orlando, Florida, 32801, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

Sheppard Pratt Health System

Towson, Maryland, 21204, United States

Location

Adams Clinical Boston

Boston, Massachusetts, 02116, United States

Location

Princeton Medical Institute

Princeton, New Jersey, 08540, United States

Location

University of Cincinnati Psychiatry- Anxiety Disorders Research Program

Cincinnati, Ohio, 45219, United States

Location

Neuro-Behavioral Clinical Research, Inc.

North Canton, Ohio, 44720, United States

Location

Austin Clinical Trial Partners

Austin, Texas, 78737, United States

Location

Cedar Clinical Research

Murray, Utah, 84107, United States

Location

Core Clinical Research

Everett, Washington, 98201, United States

Location

A-shine s.r.o.

Pilsen, Czechia

Location

Institut Neuropsychiatricke Pece (INEP)

Prague, Czechia

Location

Psyon s.r.o.

Prague, Czechia

Location

Cabinet Dr.Desbonnet : Résidence Saint Michel

Douai, France

Location

Hôpital Conception, CIC Centre, bat néphrologie 3eme étage

Marseille, France

Location

CMME

Paris, France

Location

GHU Paris Psychiatrie et Neurosciences

Paris, France

Location

Centre Hospitalier du Rouvray

Sotteville-lès-Rouen, France

Location

Department of Psychiatry and Psychotherapy Campus Charité Mitte Charité Universitätsmedizin Berlin

Berlin, Germany

Location

OVID Clinic Berlin

Berlin, Germany

Location

Central Institute of Mental Health

Mannheim, Germany

Location

Klinik für Psychiatrie und Psychotherapie, Abt: Allgemeine Psychiatrie und Psychotherapie

Tübingen, Germany

Location

Centrum Badan Klinicznych PI-House sp. z o.o.

Gdansk, Poland

Location

Department of Psychiatry, UCK

Gdansk, Poland

Location

Department of Affective and Psychotic Disorders, Central Teaching Hospital, Medical University of Lodz

Lodz, Poland

Location

Neuroclin Glasgow

Glasgow, United Kingdom

Location

Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust, St. Nicholas Hospital

Gosforth, United Kingdom

Location

4 Medical Clinical Solutions

London, United Kingdom

Location

Clerkenwell Health - Baker Street

London, United Kingdom

Location

Clerkenwell Health

London, United Kingdom

Location

South London and Maudsley NHS Foundation Trust of The Maudsley Hospital

London, United Kingdom

Location

4 Medical Clinical Solutions

Manchester, United Kingdom

Location

St George's Community Health Centre

Sheffield, United Kingdom

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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 5, 2025
• Study Start: January 29, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 22, 2026

Record last verified: 2025-05

Locations

FR (5); DE (4); PL (3); US (14); CZ (3); GB (8)