A Randomized, Double-blind, Placebo-controlled Study to Determine Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 5
- 主要终点
- Absolute change from baseline in the Positive and Negative Syndrome Scale - Excited Component (PEC) total score
研究概览
简要总结
This is a study of the efficacy and safety of BXCL501 in children and adolescents with acute agitation and either bipolar disorder or schizophrenia.
详细描述
The study will enroll approximately 140 subjects randomized to dose regimens of 80 µg or 120 µg BCXL501 or placebo (Group one), or 60 µg BCXL501 or placebo (Group two; Europe only). Subjects with acute agitation will include male and female children and adolescents who are either newly admitted to a hospital setting or already admitted and experiencing acute agitation. Subjects will be domiciled in a clinical research setting or hospitalized to remain under medical supervision while undergoing screening procedures to assess eligibility. Efficacy and safety assessments will be conducted periodically before and after dosing.
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
- Double (Participant, Investigator)
盲法说明
Double-Blind, Placebo-controlled
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects between the ages of 10-17 years, inclusive, with bipolar disorder (DSM-5 criteria) and 13-17 years, inclusive, in subjects with schizophrenia (DSM-5 criteria).
- •Patients who are judged to be clinically agitated at Screening and Baseline with a total score of ≥14 on the 5 items comprising the PANSS Excited Component (PEC).
- •Patients who have a score of ≥ 4 on at least 1 of the 5 items on the PEC at Baseline.
- •Participants who agree to use a medically acceptable and effective birth control method
排除标准
- •Patients with agitation caused by acute intoxication, including alcohol or drugs of abuse (with the exception of THC) during urine screening.
- •Use of benzodiazepines or other hypnotics or oral or short-acting intramuscular antipsychotic drugs in the 4 hours before study treatment.
- •Patients who are judged to be at significant risk of suicide.
- •Patients with serious or unstable medical illnesses.
- •Patients who have received an investigational drug within 30 days prior to the current agitation episode.
- •Patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving the study drug.
研究组 & 干预措施
80 Micrograms
Sublingual film containing 80 micrograms Dexmedetomidine
干预措施: BXCL501 80 Micrograms (Drug)
120 Micrograms
Sublingual film containing 120 micrograms Dexmedetomidine
干预措施: BXCL501 120 Micrograms (Drug)
Placebo
Sublingual Placebo film
干预措施: Placebo Film (Drug)
60 Micrograms
Sublingual film containing 60 micrograms Dexmedetomidine Europe Only
干预措施: BXCL501 60 Micrograms (Drug)
结局指标
主要结局
Absolute change from baseline in the Positive and Negative Syndrome Scale - Excited Component (PEC) total score
时间窗: 120 minutes - Group one only
The Positive and Negative Syndrome Scale - Excited Component (PEC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe)
次要结局
- Absolute change from baseline in the Positive and Negative Syndrome Scale - Excited Component (PEC) total score(90, 60, 45, 30, 20,10 minutes - Group one only)