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

Generalized Anxiety Disorder (GAD) Clinical Trial

Official title:

A Randomized Double-Blind, Placebo Controlled, Flexible Dose, Parallel Group Study of Extended-Release Lorazepam (EDG004) for the Treatment of Generalized Anxiety Disorder (GAD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02305797
• Other study ID #: EDG004-003
• Status: Completed
• Phase: Phase 3
• Start date: January 2015
• Est. completion date: May 2016

Study information

• Verified date: July 2016
• Source: Edgemont Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 495
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Generalized Anxiety Disorder (GAD)

Intervention

Drug:
• Extended-release lorazepam
Extended-release lorazepam capsules
• Placebo
Placebo capsules

Locations

Country	Name	City	State
United States	Multiple Investigational Sites	Multiple Locations	California

Sponsors (1)

Lead Sponsor	Collaborator
Edgemont Pharmaceuticals, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Visit 7 (Day 42)	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.	Day 42 (Visit 7)
Secondary	Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Visit 7 (Day 42)	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.	Day 42 (Visit 7)