Trial · NCT02305797

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

NCT02305797, Phase 3, Completed, Edgemont Pharmaceuticals, LLC; results first posted 2018-09-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. EDG004 Treatment of Adult Patients With Generalized Anxiety Disorder (GAD). Trials, record NCT02305797. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02305797

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: EDG004 Treatment of Adult Patients With Generalized Anxiety Disorder (GAD)
NCT number: NCT02305797
Status: Completed
Phases: Phase 3
Enrollment: 495 participants, actual
Lead sponsor: Edgemont Pharmaceuticals, LLC
Conditions: Generalized Anxiety Disorder (GAD)
Interventions: Extended-release lorazepam, Placebo
First posted: 2014-12-03
Last updated: 2018-09-26
Results first posted: 2018-09-26

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Visit 7 (Day 42)	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	Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Visit 7 (Day 42)	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.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Visit 7 (Day 42)	Day 42 (Visit 7)	A total of 495 patients were randomly assigned to a treatment group and received at least one dose of study treatment. The mITT Set included 239 patients randomly assigned to EDG004 and 240 patients randomly assigned to placebo.	Score on scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Visit 7 (Day 42)	Day 42 (Visit 7)	The modified Intent-to-treat (mITT) population was used for all analyses.	CGI-S score	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Visit 7 (Day 42)	EDG004	-9.01	Standard Error 0.47	Score on scale
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Visit 7 (Day 42)	Placebo	-8.93	Standard Error 0.48	Score on scale
Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Visit 7 (Day 42)	EDG004	-1.14	Standard Error 0.072	CGI-S score
Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Visit 7 (Day 42)	Placebo	-1.10	Standard Error 0.071	CGI-S score

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	EDG004	247
Overall Study	STARTED	Placebo	248
Overall Study	COMPLETED	EDG004	202
Overall Study	COMPLETED	Placebo	210
Overall Study	NOT COMPLETED	EDG004	45
Overall Study	NOT COMPLETED	Placebo	38

Source ClinicalTrials.gov

Adverse events14

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nausea	Gastrointestinal disorders	EDG004	18	247	21
other	Nausea	Gastrointestinal disorders	Placebo	13	248	15
other	Fatigue	General disorders	EDG004	32	247	36
other	Fatigue	General disorders	Placebo	7	248	7
other	Headache	Nervous system disorders	EDG004	16	247	19
other	Headache	Nervous system disorders	Placebo	19	248	26
other	Dizziness	Nervous system disorders	EDG004	23	247	23
other	Dizziness	Nervous system disorders	Placebo	9	248	10
other	Somnolence	Nervous system disorders	EDG004	42	247	50
other	Somnolence	Nervous system disorders	Placebo	16	248	16

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	EDG004
Total, all-cause mortality	Placebo
Total, other adverse events	EDG004	131	247
Total, other adverse events	Placebo	64	248
Total, serious adverse events	EDG004	2	247
Total, serious adverse events	Placebo	0	248

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
EDG004 vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02305797

GET https://conductscience.org/api/trials/v1/NCT02305797/registered

API reference For AI assistants