ENCALM: a Study of ENX-102 As a Monotherapy Treatment in Patients with Generalized Anxiety Disorder

Description

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

Conditions

Generalized Anxiety Disorder

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Study Overview

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Study Details

Study overview

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

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

ENCALM: a Study of ENX-102 As a Monotherapy Treatment in Patients with Generalized Anxiety Disorder

Condition
Generalized Anxiety Disorder
Intervention / Treatment

-

Contacts and Locations

Phoenix

IMA Clinical Research Phoenix, Phoenix, Arizona, United States, 85012

Garden Grove

Collaborative Neuroscience Research, LLC (CNS), Garden Grove, California, United States, 92845

Imperial

Sun Valley Research Center, Imperial, California, United States, 92251

Los Angeles

NRC Research Institute, Los Angeles, California, United States, 90015

Los Angeles

Alliance Research, Los Angeles, California, United States, 90807

Oceanside

Excell Research, Inc., Oceanside, California, United States, 92056

Redlands

Anderson Clinical Research, Redlands, California, United States, 92374

Sherman Oaks

California Neuroscience Research, LLC, Sherman Oaks, California, United States, 91403

Walnut Creek

Sunwise Clincial Research, Walnut Creek, California, United States, 94596

Denver

Mountain View Clinical Research, Denver, Colorado, United States, 80209

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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
  • * 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Engrail Therapeutics INC,

Estibaliz Arce, PhD, STUDY_DIRECTOR, Engrail Therapeutics INC

Study Record Dates

2025-12