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

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Conditions

Generalized Anxiety Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2023-07-03
Study Completion:2025-09-18
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05749055

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female at birth, inclusive of any gender identity, aged 18 to 65 years, inclusive, at Screening
  2. * 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
  3. * 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
  1. * Clinically predominant psychiatric diagnosis other than GAD as confirmed by the MINI
  2. * 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
  3. * Reports moderately severe to severe symptoms of depression
  4. * 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
  5. * Recent suicidal ideation or behavior
  6. * Current or recent moderate to severe substance use disorder as assessed by the MINI
  7. * Clinically significant abnormal findings in safety assessments
  8. * Has significant progressive disorders or unstable medical conditions
  9. * Unable to comply with the requirements of the study or, in the opinion of the Investigator or Sponsor, is unsuitable for the study

Contacts and Locations

Principal Investigator

Estibaliz Arce, PhD
STUDY_DIRECTOR
Engrail Therapeutics INC

Study Locations (Sites)

IMA Clinical Research Phoenix
Phoenix, Arizona, 85012
United States
Collaborative Neuroscience Research, LLC (CNS)
Garden Grove, California, 92845
United States
Sun Valley Research Center
Imperial, California, 92251
United States
Alliance Research
Long Beach, California, 90712
United States
NRC Research Institute
Los Angeles, California, 90015
United States
Excell Research, Inc.
Oceanside, California, 92056
United States
Anderson Clinical Research
Redlands, California, 92374
United States
California Neuroscience Research, LLC
Sherman Oaks, California, 91403
United States
Pacific Clinical Research Management Group
Upland, California, 91786
United States
Sunwise Clinical Research
Walnut Creek, California, 94596
United States
Mountain View Clinical Research
Denver, Colorado, 80209
United States
Vertex Clinical Research
Clermont, Florida, 34711
United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256
United States
Accel Research Sites Network - Lakeland CRU
Lakeland, Florida, 33803
United States
Accel Research Sites Network - Maitland CRU
Maitland, Florida, 32751
United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801
United States
CenExel iResearch, LLC
Savannah, Georgia, 31405
United States
Collective Medical Research
Overland Park, Kansas, 66210
United States
Boston Clinical Trials
Boston, Massachusetts, 02131
United States
Precise Research Centres
Flowood, Mississippi, 39232
United States
IMA Clinical Research
Las Vegas, Nevada, 89102
United States
SPRI Clinical Trials, LLC
Brooklyn, New York, 11235
United States
Neurobehavioral Research
Cedarhurst, New York, 11516
United States
Richmond Behavioral Associates
Staten Island, New York, 10314
United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119
United States
Austin Clinical Trials Partners
Austin, Texas, 78737
United States
FutureSearch Trials of Dallas
Dallas, Texas, 75231
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Aim Trials
Plano, Texas, 75093
United States
Grayline Research Center
Wichita Falls, Texas, 76309
United States
Alpine Research Organization
Clinton, Utah, 84015
United States
Core Clinical Research
Everett, Washington, 98201
United States

Collaborators and Investigators

Sponsor: Engrail Therapeutics INC

  • Estibaliz Arce, PhD, STUDY_DIRECTOR, Engrail Therapeutics INC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-03
Study Completion Date2025-09-18

Study Record Updates

Study Start Date2023-07-03
Study Completion Date2025-09-18

Terms related to this study

Additional Relevant MeSH Terms

  • Generalized Anxiety Disorder