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A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (Panorama)
NCT06809595 · Definium Therapeutics US, Inc.
In plain English
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Official title
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 - Panorama
About this study
The study will enroll up to 375 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.
Eligibility criteria
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 design
Enrollment target: 250 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2025-01-29
Estimated completion: 2027-05
Last updated: 2026-03-13
Interventions
Other: PlaceboDrug: MM120 (LSD D-Tartrate)
Primary outcomes
- • Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at Week 12 (Baseline to Week 12)
Sponsor
Definium Therapeutics US, Inc. · industry
Contacts & investigators
ContactDefinium Therapeutics Clinical Trials Info Requests · contact · clinicaltrials@definiumtx.com · 1-332-282-0479
All locations (38)
Preferred Research Partners, Inc.Recruiting
Little Rock, Arkansas, United States
Psychedelic Science InstituteRecruiting
Los Angeles, California, United States
West Los Angeles VA Medical CenterNot Yet Recruiting
Los Angeles, California, United States
Cenexel-CNSWithdrawn
Torrance, California, United States
Bradenton Research Center, Inc.Recruiting
Bradenton, Florida, United States
Clinical Neuroscience Solutions, IncRecruiting
Orlando, Florida, United States
Atlanta Center for Medical ResearchActive Not Recruiting
Atlanta, Georgia, United States
Sheppard Pratt Health SystemRecruiting
Towson, Maryland, United States
Adams Clinical BostonActive Not Recruiting
Boston, Massachusetts, United States
Princeton Medical InstituteRecruiting
Princeton, New Jersey, United States
University of Cincinnati Psychiatry- Anxiety Disorders Research ProgramRecruiting
Cincinnati, Ohio, United States
Neuro-Behavioral Clinical Research, Inc.Recruiting
North Canton, Ohio, United States
Austin Clinical Trial PartnersRecruiting
Austin, Texas, United States
Cedar Clinical ResearchRecruiting
Murray, Utah, United States
Core Clinical ResearchRecruiting
Everett, Washington, United States
A-shine s.r.o.Recruiting
Pilsen, Czechia
Institut Neuropsychiatricke Pece (INEP)Recruiting
Prague, Czechia
Psyon s.r.o.Recruiting
Prague, Czechia
Cabinet Dr.Desbonnet : Résidence Saint MichelRecruiting
Douai, France
Hôpital Conception, CIC Centre, bat néphrologie 3eme étageRecruiting
Marseille, France
CMMERecruiting
Paris, France
GHU Paris Psychiatrie et NeurosciencesRecruiting
Paris, France
Centre Hospitalier du RouvrayRecruiting
Sotteville-lès-Rouen, France
Department of Psychiatry and Psychotherapy Campus Charité Mitte Charité Universitätsmedizin BerlinRecruiting
Berlin, Germany
OVID Clinic BerlinRecruiting
Berlin, Germany
Central Institute of Mental HealthRecruiting
Mannheim, Germany
Klinik für Psychiatrie und Psychotherapie, Abt: Allgemeine Psychiatrie und PsychotherapieRecruiting
Tübingen, Germany
Centrum Badan Klinicznych PI-House sp. z o.o.Recruiting
Gdansk, Poland
Department of Psychiatry, UCKRecruiting
Gdansk, Poland
Department of Affective and Psychotic Disorders, Central Teaching Hospital, Medical University of LodzRecruiting
Lodz, Poland
Neuroclin GlasgowRecruiting
Glasgow, United Kingdom
Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust, St. Nicholas HospitalRecruiting
Gosforth, United Kingdom
4 Medical Clinical SolutionsRecruiting
London, United Kingdom
Clerkenwell Health - Baker StreetRecruiting
London, United Kingdom
Clerkenwell HealthRecruiting
London, United Kingdom
South London and Maudsley NHS Foundation Trust of The Maudsley HospitalRecruiting
London, United Kingdom
4 Medical Clinical SolutionsRecruiting
Manchester, United Kingdom
St George's Community Health CentreRecruiting
Sheffield, United Kingdom