NCT02305797

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 495 (actual)
• Sponsor: Edgemont Pharmaceuticals, LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Generalized Anxiety Disorder (GAD)

Interventions

Type	Name	Description
DRUG	Extended-release lorazepam	Extended-release lorazepam capsules
DRUG	Placebo	Placebo capsules

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2014-12-03
• Last updated: 2018-09-26
• Results posted: 2018-09-26

Locations

1 site across 1 country: United States