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A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (Voyage)
NCT06741228 · 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 - Voyage
About this study
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.
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: 200 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2024-12-11
Estimated completion: 2026-11
Last updated: 2026-02-27
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 (36)
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Boston, Massachusetts, United States
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Columbia, Missouri, United States
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New York, New York, United States
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New York, New York, United States
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The Bronx, New York, United States
Cleveland Clinic Lutheran HospitalRecruiting
Cleveland, Ohio, United States
Summit Headlands LLCRecruiting
Portland, Oregon, United States
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Moosic, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
Coastal Carolina Research CenterRecruiting
North Charleston, South Carolina, United States
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