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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2016

Interventions

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

Arms, Groups and Cohorts

  • Experimental: EDG004
    • EDG004 – Extended release lorazepam capsules
  • Placebo Comparator: Placebo
    • Placebo

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Edgemont Pharmaceuticals, LLC
  • Provider of Information About this Clinical Study
    • Sponsor

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