drugset / Trial / NCT02305797

EDG004 Treatment of Adult Patients With Generalized Anxiety Disorder (GAD)

NCT02305797

Phase 3 Completed 495 enrolled Edgemont Pharmaceuticals, LLC
RandomizedParallel-groupQuadruple-blindTreatment

Summary

To 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.

Timeline

Start
2015-01
Primary completion
2016-05
Completion
2016-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Lorazepam Small molecule