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

Phase 3

Completed

• Conditions: Generalized Anxiety Disorder (GAD)
• Interventions: Drug: Extended-release lorazepam; Drug: Placebo

• Registration Number: NCT02305797
• Lead Sponsor: Edgemont Pharmaceuticals, LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-25
• Study First Submitted QC: 2014-11-28
• Study First Posted: 2014-12-03
• Study Start: 2015-01
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-07
• Results First Submitted: 2018-07-20
• Results First Submitted QC: 2018-08-28
• Last Update Submitted: 2018-08-28
• Results First Posted: 2018-09-26
• Last Update Posted: 2018-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 495

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EDG004	Extended-release lorazepam	EDG004 - Extended release lorazepam capsules
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Visit 7 (Day 42)	Day 42 (Visit 7)	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Visit 7 (Day 42)	Day 42 (Visit 7)	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.

Trial Locations

Locations (1)

Multiple Investigational Sites; 🇺🇸 Multiple Locations, California, United States