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Completed

NCT Number: NCT02305797

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

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.

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Key information

Conditions

Generalized Anxiety Disorder (GAD) Anxiety Disorders Generalized Anxiety Disorder Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Multiple Investigational Sites

Multiple Locations, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Extended-release lorazepam

Drug

Extended-release lorazepam capsules

Other names: EDG004

Placebo

Drug

Placebo capsules

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Edgemont Pharmaceuticals, LLC

Industry

Registry information

Official study 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)

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 3, 2014
Registry last updated
Sep 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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