A Study to Evaluate the Efficacy and Safety of ENX-102 in Participants With Social Anxiety Disorder
NCT ID: NCT07193563
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
47 participants
INTERVENTIONAL
2025-09-05
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ENX-102
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.
ENX-102
oral capsule
Placebo
Participants will receive ENX-102 matching placebo in capsule once daily for 10 weeks
Placebo
oral capsule
Interventions
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ENX-102
oral capsule
Placebo
oral capsule
Eligibility Criteria
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Inclusion Criteria
* LSAS total score of ≥70
* CGI-S score of ≥4
Exclusion Criteria
* Any past/lifetime or current diagnosis of a neurocognitive disorder or psychotic disorder, or any current diagnosis of posttraumatic stress disorder, obsessive compulsive disorder, or bipolar disorder
* Reports moderately severe to severe symptoms of depression
* Frequent use of benzodiazepines within 90 days of screening
* Used prohibited medication or prohibited herbal or other supplements within 5 half- lives or 21 days prior to Day 1 and unwillingness to refrain from their use for the duration of the trial
* Recent suicidal ideation or behavior
* Current or recent moderate or severe substance use disorder as assessed by the MINI
* Is unwilling/unable to abstain from alcohol, marijuana, THC, CBD, and/or any other psychoactive substances (except for nicotine or caffeine) for the duration of the trial, per Investigator judgment, and/or has a positive alcohol test or drug test at Screening or Day 1
* Clinically significant abnormal findings in safety assessments
* Has significant progressive disorders or unstable medical conditions Unable to comply with the requirements of the study or, in the opinion of the Investigator or Sponsor, is unsuitable for the study
18 Years
70 Years
ALL
No
Sponsors
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Engrail Therapeutics INC
INDUSTRY
Responsible Party
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Locations
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IMA Clinical Research Phoenix
Phoenix, Arizona, United States
University of California
La Jolla, California, United States
Neuroresearch Group
Los Angeles, California, United States
Excell Research, Inc.
Oceanside, California, United States
Anderson Clinical Research
Redlands, California, United States
California Neuroscience Research, LLC
Sherman Oaks, California, United States
Sunwise Clincial Research
Walnut Creek, California, United States
Mountain View Clinical Research
Denver, Colorado, United States
CNS Health
Jacksonville, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
CenExel iResearch, LLC
Savannah, Georgia, United States
IMA Clinical Research
Las Vegas, Nevada, United States
Redbird Research
Las Vegas, Nevada, United States
Cenexel HRI
Berlin, New Jersey, United States
SPRI Clinical Trials, LLC
Brooklyn, New York, United States
Neurobehavioral Research, Inc.
Cedarhurst, New York, United States
Clinical Neurosciences, Inc
Memphis, Tennessee, United States
Austin Clinical Trials Partners
Austin, Texas, United States
Grayline Research Center
Wichita Falls, Texas, United States
Core Clinical Research
Everett, Washington, United States
Countries
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Other Identifiers
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ENX-102-005
Identifier Type: -
Identifier Source: org_study_id
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