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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

Location

RECRUITING

United States, California

Sun Valley Research Center

Imperial, California, United States, 92251

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

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