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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 252
- 试验地点
- 30
- 主要终点
- To evaluate the efficacy of ENX-102 versus placebo in patients with generalized anxiety disorder (GAD)
研究概览
简要总结
The ENCALM trial is designed to evaluate the efficacy and safety of ENX-102 in patients diagnosed with generalized anxiety disorder (GAD)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: ENX-102 (Drug)
Placebo
Nine weeks of placebo in capsule form taken orally once daily in the evening for a 9-week total treatment period.
干预措施: Placebo (Drug)
结局指标
主要结局
To evaluate the efficacy of ENX-102 versus placebo in patients with generalized anxiety disorder (GAD)
时间窗: 4 weeks
Mean change from baseline on the Hamilton Anxiety Rating Scale (HAM-A) total score \[14 symptoms with each symptom scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56 and higher scores representing worse outcomes\]
次要结局
未报告次要终点