ENCALM: A Study of ENX-102 as a Monotherapy Treatment in Patients With Generalized Anxiety Disorder
- Registration Number
- NCT05749055
- Lead Sponsor
- Engrail Therapeutics INC
- Brief Summary
The ENCALM trial is designed to evaluate the efficacy and safety of ENX-102 in patients diagnosed with generalized anxiety disorder (GAD)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 252
- 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
- Clinically predominant psychiatric diagnosis other than GAD as confirmed by the MINI
- Any past/lifetime or current diagnosis of a neurocognitive disorder, post traumatic stress disorder, obsessive compulsive disorder, psychotic disorder, or bipolar disorder
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Nine weeks of placebo in capsule form taken orally once daily in the evening for a 9-week total treatment period. ENX-102 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.
- Primary Outcome Measures
Name Time Method 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 \[14 symptoms with each symptom scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56 and higher scores representing worse outcomes\]
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (30)
IMA Clinical Research Phoenix
🇺🇸Phoenix, Arizona, United States
Collaborative Neuroscience Research, LLC (CNS)
🇺🇸Garden Grove, California, United States
Sun Valley Research Center
🇺🇸Imperial, California, United States
Alliance Research
🇺🇸Long Beach, California, United States
NRC Research Institute
🇺🇸Los Angeles, California, United States
Excell Research, Inc.
🇺🇸Oceanside, California, United States
Anderson Clinical Research
🇺🇸Redlands, California, United States
California Neuroscience Research, LLC
🇺🇸Sherman Oaks, California, United States
Pacific Clinical Research Management Group
🇺🇸Upland, California, United States
Sunwise Clinical Research
🇺🇸Walnut Creek, California, United States
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