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

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Engrail Therapeutics INC

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

• Clinically significant psychiatric co-morbidities as assessed by the MINI

• Reports moderately severe to severe symptoms of depression

• Ingested psychotropic medication within 5 half-lives or 35 days (whichever is longer) prior to Screening, 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