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

NCT05749055 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: ENX-102-003
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 32

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

ENX-102

EXPERIMENTAL

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.

Drug: ENX-102

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

ENX-102 DRUG

Selective GABA-A alpha2,3,5 positive allosteric modulator

ENX-102

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Engrail Therapeutics INC: lead

Study Sites (32)

IMA Clinical Research Phoenix

Phoenix, Arizona, 85012, United States

Location

Collaborative Neuroscience Research, LLC (CNS)

Garden Grove, California, 92845, United States

Location

Sun Valley Research Center

Imperial, California, 92251, United States

Location

Alliance Research

Long Beach, California, 90712, United States

Location

NRC Research Institute

Los Angeles, California, 90015, United States

Location

Excell Research, Inc.

Oceanside, California, 92056, United States

Location

Anderson Clinical Research

Redlands, California, 92374, United States

Location

California Neuroscience Research, LLC

Sherman Oaks, California, 91403, United States

Location

Pacific Clinical Research Management Group

Upland, California, 91786, United States

Location

Sunwise Clinical Research

Walnut Creek, California, 94596, United States

Location

Mountain View Clinical Research

Denver, Colorado, 80209, United States

Location

Vertex Clinical Research

Clermont, Florida, 34711, United States

Location

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32256, United States

Location

Accel Research Sites Network - Lakeland CRU

Lakeland, Florida, 33803, United States

Location

Accel Research Sites Network - Maitland CRU

Maitland, Florida, 32751, United States

Location

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, 32801, United States

Location

CenExel iResearch, LLC

Savannah, Georgia, 31405, United States

Location

Collective Medical Research

Overland Park, Kansas, 66210, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

Location

Precise Research Centres

Flowood, Mississippi, 39232, United States

Location

IMA Clinical Research

Las Vegas, Nevada, 89102, United States

Location

SPRI Clinical Trials, LLC

Brooklyn, New York, 11235, United States

Location

Neurobehavioral Research

Cedarhurst, New York, 11516, United States

Location

Richmond Behavioral Associates

Staten Island, New York, 10314, United States

Location

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, 38119, United States

Location

Austin Clinical Trials Partners

Austin, Texas, 78737, United States

Location

FutureSearch Trials of Dallas

Dallas, Texas, 75231, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Aim Trials

Plano, Texas, 75093, United States

Location

Grayline Research Center

Wichita Falls, Texas, 76309, United States

Location

Alpine Research Organization

Clinton, Utah, 84015, United States

Location

Core Clinical Research

Everett, Washington, 98201, United States

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Estibaliz Arce, PhD

  Engrail Therapeutics INC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2023
• First Posted: March 1, 2023
• Study Start: July 3, 2023
• Primary Completion: September 18, 2025
• Study Completion: September 18, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (32)