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.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at Week 12
Time frame: Baseline to Week 12
Secondary Endpoints
Change from Baseline in HAM-A total score at 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
HAM-A remission (total score ≤7) at each timepoint assessed during the 12-week double-blind treatment period
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
✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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