Generalized Anxiety Disorder (GAD)
Conditions
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.
Interventions
DRUGExtended-release lorazepam
Extended-release lorazepam capsules
DRUGPlacebo
Placebo capsules
Sponsors
Edgemont Pharmaceuticals, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
The study was conducted in 44 centers in the United States.
Pre-assignment details
Patients were evaluated for eligibility during a screening period and underwent a washout from prior and concomitant medications using protocol-specified guidelines, where applicable.
Participants by arm
| Arm | Count |
|---|---|
| EDG004 EDG004
EDG004: EDG004 | 239 |
| Placebo Placebo
Placebo: Placebo | 240 |
| Total | 479 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 11 | 2 |
| Overall Study | Lack of Efficacy | 6 | 0 |
| Overall Study | Lost to Follow-up | 5 | 11 |
| Overall Study | Noncompliance | 14 | 12 |
| Overall Study | Pregnancy | 0 | 2 |
| Overall Study | Reason not collected | 0 | 1 |
| Overall Study | Withdrawal by Subject | 9 | 10 |
Baseline characteristics
| Characteristic | EDG004 | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 36.4 years STANDARD_DEVIATION 12.36 | 35.9 years STANDARD_DEVIATION 11.96 | 36.2 years STANDARD_DEVIATION 12.15 |
| Region of Enrollment United States | 239 participants | 240 participants | 479 participants |
| Sex: Female, Male Female | 68 Participants | 70 Participants | 138 Participants |
| Sex: Female, Male Male | 171 Participants | 170 Participants | 341 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 131 / 247 | 64 / 248 |
| serious Total, serious adverse events | 2 / 247 | 0 / 248 |
Outcome results
Primary
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| EDG004 | 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 |
| Placebo | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Visit 7 (Day 42) | -8.93 Score on scale | Standard Error 0.48 |
Secondary
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.
Time frame: Day 42 (Visit 7)
Population: The modified Intent-to-treat (mITT) population was used for all analyses.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| EDG004 | 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 |
| Placebo | Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Visit 7 (Day 42) | -1.10 CGI-S score | Standard Error 0.071 |