A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (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
Sponsor: Definium Therapeutics US, Inc.
This observational or N/A phase trial investigates Generalized Anxiety Disorder and is currently ongoing. Definium Therapeutics US, Inc. leads this study, which shows 15 recorded versions since 2024 — indicating substantial longitudinal coverage. This study adds to the longitudinal dataset for psychiatric treatment development.
Study Description(click to expand)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.
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.
Status Flow
Change History
15 versions recorded-
May 4, 2026 — Present [daily]
Active Not Recruiting
Status: Recruiting → Active Not Recruiting · Phase: PHASE3 → None
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Feb 2026 — May 2026 [monthly]
Recruiting PHASE3
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Jan 2026 — Feb 2026 [monthly]
Recruiting PHASE3
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Dec 2025 — Jan 2026 [monthly]
Recruiting PHASE3
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Nov 2025 — Dec 2025 [monthly]
Recruiting PHASE3
▶ Show 10 earlier versions
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Oct 2025 — Nov 2025 [monthly]
Recruiting PHASE3
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Sep 2025 — Oct 2025 [monthly]
Recruiting PHASE3
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Aug 2025 — Sep 2025 [monthly]
Recruiting PHASE3
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Jul 2025 — Aug 2025 [monthly]
Recruiting PHASE3
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Jun 2025 — Jul 2025 [monthly]
Recruiting PHASE3
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May 2025 — Jun 2025 [monthly]
Recruiting PHASE3
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Apr 2025 — May 2025 [monthly]
Recruiting PHASE3
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Mar 2025 — Apr 2025 [monthly]
Recruiting PHASE3
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Feb 2025 — Mar 2025 [monthly]
Recruiting PHASE3
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Jan 2025 — Feb 2025 [monthly]
Recruiting PHASE3
First recorded
Dec 2024
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility 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
Contact Information
- Definium Therapeutics US, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .