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

Generalized Anxiety Disorder Clinical Trial

— ENCALM  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05749055
• Other study ID #: ENX-102-003
• Status: Recruiting
• Phase: Phase 2
• Start date: July 3, 2023
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: Engrail Therapeutics INC
• Contact: Eve Taylor, PhD
• Phone: 858-342-5478
• Email: ENCALM[@]engrail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 or current diagnosis of a neurocognitive disorder, post traumatic stress disorder, obsessive compulsive disorder, psychotic disorder, or bipolar disorder

• 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

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Drug:
• ENX-102
Selective GABA-A alpha2,3,5 positive allosteric modulator
• Placebo
Placebo

Locations

Country	Name	City	State
United States	IMA Clinical Research Albuquerque	Albuquerque	New Mexico
United States	Austin Clinical Trials Partners	Austin	Texas
United States	Boston Clinical Trials	Boston	Massachusetts
United States	SPRI Clinical Trials, LLC	Brooklyn	New York
United States	Vertex Clinical Research	Clermont	Florida
United States	North Star Medical Research	Cleveland	Ohio
United States	Alpine Research Organization	Clinton	Utah
United States	FutureSearch Trials of Dallas	Dallas	Texas
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	Mountain View Clinical Research	Denver	Colorado
United States	Sarkis Clinical Trials	Gainesville	Florida
United States	Collaborative Neuroscience Research, LLC (CNS)	Garden Grove	California
United States	Baylor College of Medicine	Houston	Texas
United States	Sun Valley Research Center	Imperial	California
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Sunwise Clincial Research	Lafayette	California
United States	Accel Research Sites Network - Lakeland CRU	Lakeland	Florida
United States	Alliance Research	Los Angeles	California
United States	NRC Research Institute	Los Angeles	California
United States	Accel Research Sites Network - Maitland CRU	Maitland	Florida
United States	Clinical Neuroscience Solutions, Inc.	Memphis	Tennessee
United States	ActivMed Practices & Research	Methuen	Massachusetts
United States	Excell Research, Inc.	Oceanside	California
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Collective Medical Research	Overland Park	Kansas
United States	IMA Clinical Research Phoenix	Phoenix	Arizona
United States	Aim Trials	Plano	Texas
United States	Anderson Clinical Research	Redlands	California
United States	CenExel iResearch, LLC	Savannah	Georgia
United States	California Neuroscience Research, LLC	Sherman Oaks	California
United States	Richmond Behavioral Associates	Staten Island	New York
United States	Grayline Research Center	Wichita Falls	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Engrail Therapeutics INC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the efficacy of ENX-102 versus placebo in patients with generalized anxiety disorder (GAD)	Mean change from baseline on the Hamilton Anxiety Rating Scale (HAM-A) total score [14 symptoms with each symptom scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56 and higher scores representing worse outcomes]	4 weeks