Back to resultsEDG004 Treatment of Adult Patients With Generalized Anxiety Disorder (GAD)
Primary Purpose
Generalized Anxiety Disorder (GAD)
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Extended-release lorazepam
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Generalized Anxiety Disorder (GAD)
Eligibility Criteria
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.
Sites / Locations
- Multiple Investigational Sites
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
EDG004
Placebo
Arm Description
EDG004 - Extended release lorazepam capsules
Placebo
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02305797
First Posted
November 25, 2014
Last Updated
August 28, 2018
Sponsor
Edgemont Pharmaceuticals, LLC
1. Study Identification
Unique Protocol Identification Number
NCT02305797
Brief Title
EDG004 Treatment of Adult Patients With Generalized Anxiety Disorder (GAD)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edgemont Pharmaceuticals, LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder (GAD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
495 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EDG004
Arm Type
Experimental
Arm Description
EDG004 - Extended release lorazepam capsules
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Extended-release lorazepam
Other Intervention Name(s)
EDG004
Intervention Description
Extended-release lorazepam capsules
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules
Primary Outcome Measure Information:
Title
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Visit 7 (Day 42)
Description
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.
Time Frame
Day 42 (Visit 7)
Secondary Outcome Measure Information:
Title
Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Visit 7 (Day 42)
Description
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.
Time Frame
Day 42 (Visit 7)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Multiple Investigational Sites
City
Multiple Locations
State/Province
California
Country
United States
12. IPD Sharing Statement
Learn more about this trial
EDG004 Treatment of Adult Patients With Generalized Anxiety Disorder (GAD)
We'll reach out to this number within 24 hrs