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CompletedPhase 2

ENCALM: A Study of ENX-102 as a Monotherapy Treatment in Patients With Generalized Anxiety Disorder

Key facts

Who runs it
Engrail Therapeutics INC
Where
Austin, Boston, Brooklyn, Cedarhurst, Clermont, Clinton, Dallas, Denver, Everett, Flowood, Garden Grove, Houston, Imperial, Jacksonville, Lakeland, Las Vegas, Long Beach, Los Angeles, Maitland, Memphis, Oceanside, Orlando, Overland Park, Phoenix, Plano, Redlands, Savannah, Sherman Oaks, Staten Island, Upland, Walnut Creek, and Wichita Falls, United StatesSee the 32 sites
Trial code
Status
Completed
Phase
Phase 2
People taking part
252 people enrolled
Started
3 Jul 2023
Ended
18 Sept 2025
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • ENX-102
  • Placebo
Record updated
21 September 2026

Who can take part

Age
18 years to 65 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • Male or female at birth, inclusive of any gender identity, aged 18 to 65 years, inclusive, at Screening
  • 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

Who cannot take part

  • 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
  • Clinically predominant psychiatric diagnosis other than GAD as confirmed by the MINI
  • 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
  • Current or recent moderate to severe substance use disorder as assessed by the MINI
  • Has significant progressive disorders or unstable medical conditions
  • Reports moderately severe to severe symptoms of depression
  • Recent suicidal ideation or behavior
  • Clinically significant abnormal findings in safety assessments
  • Unable to comply with the requirements of the study or, in the opinion of the Investigator or Sponsor, is unsuitable for the study

Where in United States

  • Austin Clinical Trials PartnersAustin, United States
  • Boston Clinical TrialsBoston, United States
  • SPRI Clinical Trials, LLCBrooklyn, United States
  • Neurobehavioral ResearchCedarhurst, United States
  • Vertex Clinical ResearchClermont, United States
  • Alpine Research OrganizationClinton, United States
  • FutureSearch Trials of DallasDallas, United States
  • Mountain View Clinical ResearchDenver, United States
  • Core Clinical ResearchEverett, United States
  • Precise Research CentresFlowood, United States
  • Collaborative Neuroscience Research, LLC (CNS)Garden Grove, United States
  • Baylor College of MedicineHouston, United States
  • Sun Valley Research CenterImperial, United States
  • Clinical NeuroScience Solutions IncJacksonville, United States
  • Accel Research Sites Network - Lakeland CRULakeland, United States
  • IMA Clinical ResearchLas Vegas, United States
  • Alliance ResearchLong Beach, United States
  • NRC Research InstituteLos Angeles, United States
  • Accel Research Sites Network - Maitland CRUMaitland, United States
  • Clinical Neuroscience Solutions, Inc.Memphis, United States
  • Excell Research, Inc.Oceanside, United States
  • Clinical Neuroscience Solutions, Inc.Orlando, United States
  • Collective Medical ResearchOverland Park, United States
  • IMA Clinical Research PhoenixPhoenix, United States
  • AIM TrialsPlano, United States
  • Anderson Clinical ResearchRedlands, United States
  • CenExel iResearch, LLCSavannah, United States
  • California Neuroscience Research, LLCSherman Oaks, United States
  • Richmond Behavioral AssociatesStaten Island, United States
  • Pacific Clinical Research Management GroupUpland, United States
  • Sunwise Clinical ResearchWalnut Creek, United States
  • Grayline Research CenterWichita Falls, United States

About the trial

What the trial wants to find out

The ENCALM trial is designed to evaluate the efficacy and safety of ENX-102 in patients diagnosed with generalized anxiety disorder (GAD)

The 2 groups in the trial

  • ENX-102Treatment being tested

    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.

  • PlaceboPlacebo, for comparison

    Nine weeks of placebo in capsule form taken orally once daily in the evening for a 9-week total treatment period.

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
The ENCALM Trial: A Randomized, Double-blind, Placebo-controlled Monotherapy Trial to Evaluate the Efficacy and Safety of ENX-102 in Patients With Generalized Anxiety Disorder
Record updated
21 September 2026