ENCALM: A Study of ENX-102 as a Monotherapy Treatment in Patients With Generalized Anxiety Disorder
NCT ID: NCT05749055
Last Updated: 2025-09-25
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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COMPLETED
PHASE2
252 participants
INTERVENTIONAL
2023-07-03
2025-09-18
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
Four weeks of 2 mg of ENX-102 in capsule form followed by 3 weeks of tapered dose plus 2 weeks of placebo in capsule form (before and/or after the ENX-102 treatment period), taken orally once daily in the evening for a 9-week total treatment period.
ENX-102
Selective GABA-A alpha2,3,5 positive allosteric modulator
Placebo
Nine weeks of placebo in capsule form taken orally once daily in the evening for a 9-week total treatment period.
Placebo
Placebo
Interventions
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ENX-102
Selective GABA-A alpha2,3,5 positive allosteric modulator
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with GAD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by a Mini-International Neuropsychiatric Interview (MINI) version 7.0.2
* Experiencing clinically significant generalized anxiety in need of treatment as measured by Hamilton Anxiety Rating Scale (HAM-A) Screening and Day 1 scores ≥22 and at least moderately severe score symptoms of anxious mood and tension as measured by HAM-A items 1 and 2, respectively, with score each ≥2 at Screening and Day 1
Exclusion Criteria
* Any past/lifetime/current diagnosis of a neurocognitive disorder, or psychotic disorder, or any current diagnosis of posttraumatic stress disorder, obsessive compulsive disorder or bipolar disorder confirmed by independent adjudication
* Reports moderately severe to severe symptoms of depression
* Ingested psychotropic medication within 5 half-lives or 21 days (whichever is longer) prior to Day 1, including THC and CBD, and unwillingness to refrain from their use for the entire duration of the trial
* Recent suicidal ideation or behavior
* Current or recent moderate to severe substance use disorder as assessed by the MINI
* 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
65 Years
ALL
No
Sponsors
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Engrail Therapeutics INC
INDUSTRY
Responsible Party
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Principal Investigators
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Estibaliz Arce, PhD
Role: STUDY_DIRECTOR
Engrail Therapeutics INC
Locations
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IMA Clinical Research Phoenix
Phoenix, Arizona, United States
Collaborative Neuroscience Research, LLC (CNS)
Garden Grove, California, United States
Sun Valley Research Center
Imperial, California, United States
Alliance Research
Long Beach, California, United States
NRC Research Institute
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
Pacific Clinical Research Management Group
Upland, California, United States
Sunwise Clinical Research
Walnut Creek, California, United States
Mountain View Clinical Research
Denver, Colorado, United States
Vertex Clinical Research
Clermont, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Accel Research Sites Network - Lakeland CRU
Lakeland, Florida, United States
Accel Research Sites Network - Maitland CRU
Maitland, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
CenExel iResearch, LLC
Savannah, Georgia, United States
Collective Medical Research
Overland Park, Kansas, United States
Boston Clinical Trials
Boston, Massachusetts, United States
Precise Research Centres
Flowood, Mississippi, United States
IMA Clinical Research
Las Vegas, Nevada, United States
SPRI Clinical Trials, LLC
Brooklyn, New York, United States
Neurobehavioral Research
Cedarhurst, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States
Austin Clinical Trials Partners
Austin, Texas, United States
FutureSearch Trials of Dallas
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Aim Trials
Plano, Texas, United States
Grayline Research Center
Wichita Falls, Texas, United States
Alpine Research Organization
Clinton, Utah, United States
Core Clinical Research
Everett, Washington, United States
Countries
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Other Identifiers
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ENX-102-003
Identifier Type: -
Identifier Source: org_study_id
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