IRB Study Number 25-100
Status Recruiting
Phase Phase 3
Location Lutheran Hospital
Institute Neurological Institute
Description
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.
Key inclusion and exclusion items listed below. Full eligibility criteria will be assessed during the screening period.
Inclusion Criteria
- Diagnosis of GAD per DSM-5
- Male or female aged 18 to 74
- HAM-A Total Score ≥20
Exclusion Criteria
- Certain psychiatric disorders (other than generalized anxiety disorder)
- First degree relative with or lifetime history of a psychotic disorder or bipolar disorder
- Current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine)
- Any clinically significant unstable illness
