ENCALM: a Study of ENX-102 As a Monotherapy Treatment in Patients with Generalized Anxiety Disorder
Purpose
The ENCALM trial is designed to evaluate the efficacy and safety of ENX-102 in patients diagnosed with generalized anxiety disorder (GAD)
Condition
- Generalized Anxiety Disorder
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental ENX-102 |
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. |
|
|
Placebo Comparator Placebo |
Nine weeks of placebo in capsule form taken orally once daily in the evening for a 9-week total treatment period. |
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Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Engrail Therapeutics INC
