CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 495 enrolled
Drug / intervention
Extended-release lorazepam +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02305797
NCT02305797Phase 3Completed
CompareCT.gov

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

Edgemont Pharmaceuticals, LLC·interventional·Posted Dec 3, 2014·Updated Sep 26, 2018

In Brief

A Phase 3 clinical trial evaluating Extended-release lorazepam and Placebo for Generalized Anxiety Disorder (GAD). Completed, enrolled 495 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGeneralized Anxiety Disorder (GAD)
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 3, 2014
Enrollment StartJan 1, 2015
Primary CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 11.6 years ago

Interventions

Extended-release lorazepamdrug

Extended-release lorazepam capsules

Placebodrug

Placebo capsules