A Phase 3, Multicenter, Open-label, Uncontrolled, Long-term Trial to Evaluate the Safety and Efficacy of Long-term Administration of EB-1020 Once Daily QD XR Capsules in Adults With Attention-deficit/Hyperactivity Disorder
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Number of Patients Experiencing Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety of long-term administration of mainly high doses of EB-1020 over 52 weeks in patients who have completed the double-blind trial (405-102-00112) conducted in Japan
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who completed the treatment period andfollow-up period in the preceding double-blind parent Trial (Trial 405-102-00112) and did not meet the criteria for discontinuation of the investigational medicinal product (IMP).
- •Participants who have not been found to have major problems with trial requirements, such as compliance with the IMP, in the preceding double-blind parent trial.
排除标准
- •Participants who are pregnant or breastfeeding or test positive for pregnancy on baseline visit.
- •Participants who started prohibited concomitant medications/therapies for ADHD or other comorbidities at the end of the follow-up period of the preceding trial, or participants for whom starting treatment is deemed beneficial.
- •Participants who have a significant risk of committing suicide in the opinion of the investigator or subinvestigator, or based on the following evidence:
- •Active suicidal ideation as evidenced by an answer of "yes" on Questions 4 or 5 on the section of suicidal ideation on the since last visit version of the Columbia-Suicide Severity Rating Scale (C-SSRS) in the preceding double-blind parent trial or
- •Reported suicidal behavior
- •Participants who were found to have serious or severe adverse events that were judged to be related to the IMP in the preceding double-blind parent trial.
- •Participants who test positive for drugs or alcohol in a urine test on baseline visit.
研究组 & 干预措施
EB-1020 (QD XR Capsules) 164.4 mg
干预措施: EB-1020 (Centanafadine) 164.4 mg (Drug)
EB-1020 (QD XR Capsules) 328.8 mg
干预措施: EB-1020 (Centanafadine) 328.8 mg (Drug)
结局指标
主要结局
Number of Patients Experiencing Treatment-Emergent Adverse Events (TEAEs)
时间窗: Baseline, week52
An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs are defined as AEs with an onset date on or after the first dose of IMP. They are all adverse events that started after the start of centanafadine; or if the event was continuous from baseline and was worsening, serious, study drug-related, or resulted in death, discontinuation, interruption or reduction of study therapy.
次要结局
未报告次要终点