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This is a double-blind study to evaluate the efficacy and safety of ENX-102 in participants with social anxiety disorder (SAD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ENX-102 | Experimental | Participants will receive 2 mg of ENX-102 in capsule form orally once daily for 6 weeks, followed by 2 weeks of tapered dose and up to 2 weeks of placebo in capsule form before and/or after the 8-week ENX-102 treatment period. |
|
| Placebo | Placebo Comparator | Participants will receive ENX-102 matching placebo in capsule once daily for 10 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENX-102 | Drug | oral capsule |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline on the Clinician-administered Liebowitz Social Anxiety Scale (LSAS) - Total score | The LSAS is a 24-item semi-structured interview measure of fear and avoidance experienced in a range of social and performance situations. The 24 items are divided into 2 subscales, 13 concerning performance anxiety & 11 pertaining to social situations. The 24 items are first rated on a Likert Scale from 0 to 3 on fear felt during the situations (0=none, 1=mild, 2=moderate, 3= severe), and then the same items are rated regarding avoidance of the situation (0=never, 1=occasionally, 2=often, 3=usually). An overall global score (0 to 144) is calculated by adding total fear/anxiety and total avoidance scores. Higher scores indicated higher probability of social anxiety disorder. | Baseline (Day 1) and Week 6 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IMA Clinical Research Phoenix | Phoenix | Arizona | 85012 | United States | ||
| University of California |
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| Other |
oral capsule |
|
| La Jolla |
| California |
| 92037 |
| United States |
| Neuroresearch Group | Los Angeles | California | 90025 | United States |
| Excell Research, Inc. | Oceanside | California | 92056 | United States |
| Anderson Clinical Research | Redlands | California | 92374 | United States |
| California Neuroscience Research, LLC | Sherman Oaks | California | 91403 | United States |
| Sunwise Clincial Research | Walnut Creek | California | 94596 | United States |
| Mountain View Clinical Research | Denver | Colorado | 80209 | United States |
| CNS Health | Jacksonville | Florida | 32256 | United States |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32801 | United States |
| CenExel iResearch, LLC | Savannah | Georgia | 31405 | United States |
| IMA Clinical Research | Las Vegas | Nevada | 89102 | United States |
| Redbird Research | Las Vegas | Nevada | 89119 | United States |
| Cenexel HRI | Berlin | New Jersey | 08009 | United States |
| SPRI Clinical Trials, LLC | Brooklyn | New York | 11235 | United States |
| Neurobehavioral Research, Inc. | Cedarhurst | New York | 11516 | United States |
| Clinical Neurosciences, Inc | Memphis | Tennessee | 38119 | United States |
| Austin Clinical Trials Partners | Austin | Texas | 78737 | United States |
| Grayline Research Center | Wichita Falls | Texas | 76309 | United States |
| Core Clinical Research | Everett | Washington | 98201 | United States |
| ID | Term |
|---|---|
| D000072861 | Phobia, Social |
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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