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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02305797
Recruitment Status : Completed
First Posted : December 3, 2014
Results First Posted : September 26, 2018
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Edgemont Pharmaceuticals, LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Generalized Anxiety Disorder (GAD) Drug: Extended-release lorazepam Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 495 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
Drug Information available for: Lorazepam

Arms and Interventions
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Arm Intervention/treatment
Experimental: EDG004
EDG004 - Extended release lorazepam capsules
 Drug: Extended-release lorazepam
Extended-release lorazepam capsules
Other Name: EDG004
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
Placebo capsules


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02305797


Locations
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United States, California
Multiple Investigational Sites
Multiple Locations, California, United States
Sponsors and Collaborators
Edgemont Pharmaceuticals, LLC
More Information
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Responsible Party: Edgemont Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT02305797    
Other Study ID Numbers: EDG004-003
First Posted: December 3, 2014    Key Record Dates
Results First Posted: September 26, 2018
Last Update Posted: September 26, 2018
Last Verified: July 2016
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders
Lorazepam
Anticonvulsants
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
 Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action