Clinical trial NCT05749055: ENCALM: a Study of ENX-102 As a Monotherapy Treatment in Patients with Generalized Anxiety Disorder
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Generalized Anxiety Disorder
Lead sponsor: Engrail Therapeutics INC
Sponsor class: INDUSTRY
First posted: 2023-03-01
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: To evaluate the efficacy of ENX-102 versus placebo in patients with generalized anxiety disorder (GAD)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: IMA Clinical Research Phoenix
state: Arizona
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Research, LLC (CNS)
state: California
city: Imperial
country: United States
facility: Sun Valley Research Center
state: California
city: Los Angeles
country: United States
facility: NRC Research Institute
state: California
city: Los Angeles
country: United States
facility: Alliance Research
state: California
city: Oceanside
country: United States
facility: Excell Research, Inc.
state: California
city: Redlands
country: United States
facility: Anderson Clinical Research
state: California
city: Sherman Oaks
country: United States
facility: California Neuroscience Research, LLC
state: California
city: Walnut Creek
country: United States
facility: Sunwise Clincial Research
state: California
city: Denver
country: United States
facility: Mountain View Clinical Research
state: Colorado
city: Clermont
country: United States
facility: Vertex Clinical Research
state: Florida
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Lakeland
country: United States
facility: Accel Research Sites Network - Lakeland CRU
state: Florida
city: Maitland
country: United States
facility: Accel Research Sites Network - Maitland CRU
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Savannah
country: United States
facility: CenExel iResearch, LLC
state: Georgia
city: Overland Park
country: United States
facility: Collective Medical Research
state: Kansas
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Las Vegas
country: United States
facility: IMA Clinical Research
state: Nevada
city: Albuquerque
country: United States
facility: IMA Clinical Research Albuquerque
state: New Mexico
city: Brooklyn
country: United States
facility: SPRI Clinical Trials, LLC
state: New York
city: Cedarhurst
country: United States
facility: Neurobehavioral Research
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Cleveland
country: United States
facility: North Star Medical Research
state: Ohio
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: Austin
country: United States
facility: Austin Clinical Trials Partners
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Plano
country: United States
facility: Aim Trials
state: Texas
city: Wichita Falls
country: United States
facility: Grayline Research Center
state: Texas
city: Clinton
country: United States
facility: Alpine Research Organization
state: Utah
Study officials:
affiliation: Engrail Therapeutics INC
name: Estibaliz Arce, PhD
role: STUDY_DIRECTOR
References: