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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EDG004 | Experimental | EDG004 - Extended release lorazepam capsules |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extended-release lorazepam | Drug | Extended-release lorazepam capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 42 (Visit 7) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 42 (Visit 7) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Investigational Sites | Multiple Locations | California | 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.
The study was conducted in 44 centers in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | EDG004 | EDG004 EDG004: EDG004 Extended release lorazepam capsules dosed once daily at 1, 2, 3, 4, 5, or 6 mg/day. |
| FG001 | Placebo | Placebo Placebo: Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | EDG004 | EDG004 EDG004: EDG004 |
| BG001 | Placebo | Placebo Placebo: Placebo |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | Score on scale | Day 42 (Visit 7) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EDG004 | EDG004 EDG004: EDG004 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intentional Self-Injury | Psychiatric disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Regulatory Affairs and Product Development | Cardinal Health Regulatory Sciences | 913.451.3955 | david.rhein@cardinalhealth.com |
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| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| Placebo | Drug | Placebo capsules |
|
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Pregnancy |
|
| Noncompliance |
|
| Reason not collected |
|
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Placebo
Placebo: Placebo
|
|
| 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. | The modified Intent-to-treat (mITT) population was used for all analyses. | Posted | Least Squares Mean | Standard Error | CGI-S score | Day 42 (Visit 7) |
|
|
|
| 2 |
| 247 |
| 131 |
| 247 |
| EG001 | Placebo | Placebo Placebo: Placebo | 0 | 248 | 64 | 248 |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Somnolence | Nervous system disorders | Systematic Assessment |
|
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