A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (Voyage)
Part of paid clinical trials in Gilbert, Arizona.
- Sponsor
- Definium Therapeutics US, Inc.
- Study ID
- NCT06741228
- Phase
- PHASE3
- Status
- Active Not Recruiting
Conditions
- Generalized Anxiety Disorder
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 74 Years
- Healthy Volunteers
- Not accepted
Interventions
- Placebo — OTHERA substance that is designed to have no therapeutic value
- MM120 (LSD D-Tartrate) — DRUGA psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)
Study Details
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
Key Dates
- Start date
- Dec 11, 2024
- Status verified
- May 2025
- Primary completion
- May 31, 2026
- Completion
- Nov 30, 2026
Study Design
- Enrollment
- 214 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Placebo Comparator: Arm 1 - PlaceboA substance that is designed to have no therapeutic value
- Experimental: Arm 2 - 100µg MM120 (LSD D-Tartrate)A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)
Primary Outcome Measure
Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at Week 12 [ Time Frame: Baseline to Week 12 ]
Locations (34)
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