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NCT05749055 | RECRUITING | Generalized Anxiety Disorder

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

Engrail Therapeutics INC

Brief Summary:

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

Condition or disease

Generalized Anxiety Disorder

Intervention/treatment

ENX-102

Placebo

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 280 participants
Masking : TRIPLE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2023-07-03
Estimated Primary Completion Date : 2025-12
Estimated Study Completion Date : 2025-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Key Inclusion 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
  • Key Exclusion Criteria
    • * 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
ENCALM: a Study of ENX-102 As a Monotherapy Treatment in Patients with Generalized Anxiety Disorder

Location Details

NCT05749055

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

IMA Clinical Research Phoenix

Phoenix, arizona, United States, 85012

RECRUITING

United States, California

Collaborative Neuroscience Research, LLC (CNS)

Garden Grove, California, United States, 92845

RECRUITING

United States, California

Sun Valley Research Center

Imperial, California, United States, 92251

RECRUITING

United States, California

NRC Research Institute

Los Angeles, California, United States, 90015

RECRUITING

United States, California

Alliance Research

Los Angeles, California, United States, 90807

RECRUITING

United States, California

Excell Research, Inc.

Oceanside, California, United States, 92056

RECRUITING

United States, California

Anderson Clinical Research

Redlands, California, United States, 92374

RECRUITING

United States, California

California Neuroscience Research, LLC

Sherman Oaks, California, United States, 91403

RECRUITING

United States, California

Sunwise Clincial Research

Walnut Creek, California, United States, 94596

RECRUITING

United States, Colorado

Mountain View Clinical Research

Denver, Colorado, United States, 80209

RECRUITING

United States, Florida

Vertex Clinical Research

Clermont, Florida, United States, 34711

RECRUITING

United States, Florida

Sarkis Clinical Trials

Gainesville, Florida, United States, 32607

RECRUITING

United States, Florida

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, United States, 32256

RECRUITING

United States, Florida

Accel Research Sites Network - Lakeland CRU

Lakeland, Florida, United States, 33803

RECRUITING

United States, Florida

Accel Research Sites Network - Maitland CRU

Maitland, Florida, United States, 32751

RECRUITING

United States, Florida

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, United States, 32801

RECRUITING

United States, Georgia

CenExel iResearch, LLC

Savannah, Georgia, United States, 31405

RECRUITING

United States, Kansas

Collective Medical Research

Overland Park, Kansas, United States, 66210

RECRUITING

United States, Massachusetts

Boston Clinical Trials

Boston, Massachusetts, United States, 02131

RECRUITING

United States, Nevada

IMA Clinical Research

vegas, Nevada, United States, 89102

RECRUITING

United States, New Mexico

IMA Clinical Research Albuquerque

Albuquerque, New Mexico, United States, 87109

RECRUITING

United States, New York

SPRI Clinical Trials, LLC

Brooklyn, New York, United States, 11235

RECRUITING

United States, New York

Neurobehavioral Research

Cedarhurst, New York, United States, 11516

RECRUITING

United States, New York

Richmond Behavioral Associates

Staten Island, New York, United States, 10314

RECRUITING

United States, Ohio

North Star Medical Research

Cleveland, Ohio, United States, 44130

RECRUITING

United States, Tennessee

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, United States, 38119

RECRUITING

United States, Texas

Austin Clinical Trials Partners

Austin, Texas, United States, 78737

RECRUITING

United States, Texas

FutureSearch Trials of Dallas

dallas, Texas, United States, 75231

RECRUITING

United States, Texas

Baylor College of Medicine

Houston, Texas, United States, 77030

RECRUITING

United States, Texas

Aim Trials

Plano, Texas, United States, 75093

RECRUITING

United States, Texas

Grayline Research Center

Wichita Falls, Texas, United States, 76309

RECRUITING

United States, Utah

Alpine Research Organization

Clinton, Utah, United States, 84015