Title
EDG004 Treatment of Adult Patients With Generalized Anxiety Disorder (GAD)
A Randomized Double-Blind, Placebo Controlled, Flexible Dose, Parallel Group Study of Extended-Release Lorazepam (EDG004) for the Treatment of Generalized Anxiety Disorder (GAD)
Phase
Phase 3Lead Sponsor
Edgemont Pharmaceuticals, LLCStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Generalized Anxiety Disorder (GAD)Intervention/Treatment
lorazepam ...Study Participants
495To evaluate the efficacy of EDG004 compared to placebo for the treatment of adult patients with GAD, diagnosed by Diagnostic and Statistical Manual of Mental Disorders, 5th Ed. (DSM-5) and confirmed by the Mini International Neuropsychiatric Interview (MINI 7.0). Efficacy will be measured by a statistically significant greater mean reduction from baseline compared to endpoint in anxiety symptoms as measured by the total score of the clinician-rated Hamilton Rating Scale for Anxiety (HAM-A) for the EDG004 treatment group compared to placebo.
Extended-release lorazepam capsules
Placebo capsules
Inclusion Criteria: Men and women between the ages of 18-65 years and Diagnosed with GAD and No other psychiatric conditions, and are otherwise medically healthy. Exclusion Criteria: Women who are pregnant or lactating.
| Event Type | Organ System | Event Term | EDG004 | Placebo |
|---|
HAM-A Total Score was rated by the clinician. Scores range from 0 to 56. A lower score is favorable. Baseline was defined as the last non-missing value prior to receiving double-blind study drug.
Measured on a 7-point scale 1 = Normal, not at all ill; 2 = Borderline mentally ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill. Baseline was defined as the last non-missing value prior to receiving double-blind study drug.
