Trial Outcomes & Findings for EDG004 Treatment of Adult Patients With Generalized Anxiety Disorder (GAD) (NCT NCT02305797)
NCT ID: NCT02305797
Last Updated: 2018-09-26
Results Overview
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.
COMPLETED
PHASE3
495 participants
Day 42 (Visit 7)
2018-09-26
Participant Flow
The study was conducted in 44 centers in the United States.
Patients were evaluated for eligibility during a screening period and underwent a washout from prior and concomitant medications using protocol-specified guidelines, where applicable.
Participant milestones
| Measure |
EDG004
EDG004
EDG004: EDG004
Extended release lorazepam capsules dosed once daily at 1, 2, 3, 4, 5, or 6 mg/day.
|
Placebo
Placebo
Placebo: Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
247
|
248
|
|
Overall Study
COMPLETED
|
202
|
210
|
|
Overall Study
NOT COMPLETED
|
45
|
38
|
Reasons for withdrawal
| Measure |
EDG004
EDG004
EDG004: EDG004
Extended release lorazepam capsules dosed once daily at 1, 2, 3, 4, 5, or 6 mg/day.
|
Placebo
Placebo
Placebo: Placebo
|
|---|---|---|
|
Overall Study
Adverse Event
|
11
|
2
|
|
Overall Study
Withdrawal by Subject
|
9
|
10
|
|
Overall Study
Lack of Efficacy
|
6
|
0
|
|
Overall Study
Lost to Follow-up
|
5
|
11
|
|
Overall Study
Pregnancy
|
0
|
2
|
|
Overall Study
Noncompliance
|
14
|
12
|
|
Overall Study
Reason not collected
|
0
|
1
|
Baseline Characteristics
EDG004 Treatment of Adult Patients With Generalized Anxiety Disorder (GAD)
Baseline characteristics by cohort
| Measure |
EDG004
n=239 Participants
EDG004
EDG004: EDG004
|
Placebo
n=240 Participants
Placebo
Placebo: Placebo
|
Total
n=479 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.4 years
STANDARD_DEVIATION 12.36 • n=5 Participants
|
35.9 years
STANDARD_DEVIATION 11.96 • n=7 Participants
|
36.2 years
STANDARD_DEVIATION 12.15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
171 Participants
n=5 Participants
|
170 Participants
n=7 Participants
|
341 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
239 participants
n=5 Participants
|
240 participants
n=7 Participants
|
479 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 42 (Visit 7)Population: 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.
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.
Outcome measures
| Measure |
EDG004
n=239 Participants
EDG004
EDG004: EDG004
|
Placebo
n=240 Participants
Placebo
Placebo: Placebo
|
|---|---|---|
|
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Visit 7 (Day 42)
|
-9.01 Score on scale
Standard Error 0.47
|
-8.93 Score on scale
Standard Error 0.48
|
SECONDARY outcome
Timeframe: Day 42 (Visit 7)Population: The modified Intent-to-treat (mITT) population was used for all analyses.
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.
Outcome measures
| Measure |
EDG004
n=239 Participants
EDG004
EDG004: EDG004
|
Placebo
n=240 Participants
Placebo
Placebo: Placebo
|
|---|---|---|
|
Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Visit 7 (Day 42)
|
-1.14 CGI-S score
Standard Error 0.072
|
-1.10 CGI-S score
Standard Error 0.071
|
Adverse Events
EDG004
Placebo
Serious adverse events
| Measure |
EDG004
n=247 participants at risk
EDG004
EDG004: EDG004
|
Placebo
n=248 participants at risk
Placebo
Placebo: Placebo
|
|---|---|---|
|
Psychiatric disorders
Intentional Self-Injury
|
0.40%
1/247 • Number of events 1
|
0.00%
0/248
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.40%
1/247 • Number of events 1
|
0.00%
0/248
|
Other adverse events
| Measure |
EDG004
n=247 participants at risk
EDG004
EDG004: EDG004
|
Placebo
n=248 participants at risk
Placebo
Placebo: Placebo
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
7.3%
18/247 • Number of events 21
|
5.2%
13/248 • Number of events 15
|
|
General disorders
Fatigue
|
13.0%
32/247 • Number of events 36
|
2.8%
7/248 • Number of events 7
|
|
Nervous system disorders
Headache
|
6.5%
16/247 • Number of events 19
|
7.7%
19/248 • Number of events 26
|
|
Nervous system disorders
Dizziness
|
9.3%
23/247 • Number of events 23
|
3.6%
9/248 • Number of events 10
|
|
Nervous system disorders
Somnolence
|
17.0%
42/247 • Number of events 50
|
6.5%
16/248 • Number of events 16
|
Additional Information
Director of Regulatory Affairs and Product Development
Cardinal Health Regulatory Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place