Phase 3
N=495
EDG004 Treatment of Adult Patients With Generalized Anxiety Disorder (GAD)
Generalized Anxiety Disorder (GAD)
Bottom Line
View on ClinicalTrials.gov: NCT02305797 ↗Enrolled (actual)
495
Serious AEs
0.4%
Results posted
Sep 2018
Primary outcome: Primary: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Visit 7 (Day 42) — -9.01; -8.93 Score on scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Extended-release lorazepam (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Edgemont Pharmaceuticals, LLC
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Visit 7 (Day 42) |
-9.01; -8.93 | — |
| SECONDARY Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Visit 7 (Day 42) |
-1.14; -1.10 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02305797). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.