Generalized Anxiety Disorder
Conditions
Brief summary
The ENCALM trial is designed to evaluate the efficacy and safety of ENX-102 in patients diagnosed with generalized anxiety disorder (GAD)
Interventions
DRUGENX-102
Selective GABA-A alpha2,3,5 positive allosteric modulator
DRUGPlacebo
Placebo
Sponsors
Engrail Therapeutics INC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the efficacy of ENX-102 versus placebo in patients with generalized anxiety disorder (GAD) | 4 weeks | Mean change from baseline on the Hamilton Anxiety Rating Scale (HAM-A) total score \[14 symptoms with each symptom scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56 and higher scores representing worse outcomes\] |
Countries
United States
Outcome results
None listed