Frontlight ResearchEarly access
CompletedPhase 2
A Study to Evaluate the Efficacy and Safety of ENX-102 in Participants With Social Anxiety Disorder
Key facts
- Who runs it
- Engrail Therapeutics INC
- Where
- Austin, Berlin, Brooklyn, Cedarhurst, Denver, Everett, Jacksonville, La Jolla, Las Vegas, Los Angeles, Memphis, Oceanside, Orlando, Phoenix, Redlands, Savannah, Sherman Oaks, Walnut Creek, and Wichita Falls, United StatesSee the 20 sites
- Trial code
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 47 people enrolled
- Started
- 5 Sept 2025
- Ended
- 19 Mar 2026
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- ENX-102
- Placebo
- Record updated
- 8 April 2026
Who can take part
- Age
- 18 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- Male or female at birth, aged 18-70 years, inclusive, at screening Diagnosed with SAD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR), confirmed by a Mini-International Neuropsychiatric Interview (MINI) version 7.0.2
- LSAS total score of ≥70
- CGI-S score of ≥4
Who cannot take part
- 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
- 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 predominant psychiatric diagnosis other than SAD per the MINI
- 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
- Current or recent moderate or severe substance use disorder as assessed by the MINI
- 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
- Reports moderately severe to severe symptoms of depression
- Frequent use of benzodiazepines within 90 days of screening
- Recent suicidal ideation or behavior
- Clinically significant abnormal findings in safety assessments
Where in United States
- Austin Clinical Trials PartnersAustin, United States
- Cenexel HRIBerlin, United States
- SPRI Clinical Trials, LLCBrooklyn, United States
- Neurobehavioral Research, Inc.Cedarhurst, United States
- Mountain View Clinical ResearchDenver, United States
- Core Clinical ResearchEverett, United States
- CNS HealthJacksonville, United States
- University of CaliforniaLa Jolla, United States
- IMA Clinical ResearchLas Vegas, United States
- Redbird ResearchLas Vegas, United States
- Neuroresearch GroupLos Angeles, United States
- Clinical Neurosciences, IncMemphis, United States
- Excell Research, Inc.Oceanside, United States
- Clinical Neuroscience Solutions, Inc.Orlando, United States
- IMA Clinical Research PhoenixPhoenix, United States
- Anderson Clinical ResearchRedlands, United States
- CenExel iResearch, LLCSavannah, United States
- California Neuroscience Research, LLCSherman Oaks, United States
- Sunwise Clincial ResearchWalnut Creek, United States
- Grayline Research CenterWichita Falls, United States
About the trial
What the trial wants to find out
This is a double-blind study to evaluate the efficacy and safety of ENX-102 in participants with social anxiety disorder (SAD).
The 2 groups in the trial
- ENX-102Treatment being tested
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.
- PlaceboPlacebo, for comparison
Participants will receive ENX-102 matching placebo in capsule once daily for 10 weeks
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The ENCalmSocial Trial: A Randomized, Double-Blind, Placebo-Controlled Monotherapy Trial to Evaluate the Efficacy and Safety of ENX-102 in Participants With Social Anxiety Disorder
- Record updated
- 8 April 2026