An Open-Label, Dose-Titration, Long-Term Study to Evaluate the Safety of JNS001 in Adults With Attention-Deficit/Hyperactivity Disorder at Doses of 18 mg, 27 mg, 36 mg, 45 mg, 54 mg, 63 mg or 72 mg Per Day
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 253
- 主要终点
- Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
研究概览
简要总结
The main purpose of this study is to evaluate long-term safety and tolerability of JNS001 at 18 to 72 mg per day in adults with Attention-Deficit/Hyperactivity Disorder (ADHD).
详细描述
This is a multicenter, open-label (all people involved know the identity of the intervention), dose-titration (to adjust the dose of a drug until optimal result is reached), long-term safety study in adult patients with a diagnosis of ADHD. The study consists of the Long-term phase (4-week titration period and 44-week maintenance period) and the 1-week Post-study phase. The 4 week-titration period is to find the individualized dose for each patient regardless of the treatments in the preceding study (JNS001-JPN-A01). Patients will be titrated from a starting dose of 18 mg/day for 7 days, and continue with a weekly (+/- 2 days) increment of 9 or 18 mg until an individualized dose is achieved. The titration period will be followed by a 44-week maintenance period which has combined 48-week (1-year) treatment duration with the titration period. During the maintenance period, the dose will be adjusted between 18 to 72 mg depending on the patients' symptoms. In the post-study phase, safety information will be collected after the last dose of the study treatment or premature discontinuation. The study drug will be administered with water once daily in the morning at doses of 18 mg, 27 mg, 36 mg, 45 mg, 54 mg, 63 mg, or 72 mg per day. The study treatment period is 48 weeks (titration period of 4 weeks and maintenance period of 44 weeks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients (and their legally-acceptable representative if patients are 18 or 19 years old) must have signed an Informed Consent Form (ICF) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
- •Patients who completed the preceding study (JNS001-JPN-A01), are considered to be appropriate to continue JNS001 treatment into this extension study by investigator or subinvestigator
- •Women of childbearing potential must have a negative urine pregnancy test at the final assessment in the preceding study. If sexually active, continue to use an effective method of birth control throughout the study
- •Men must agree to use a double-barrier method of birth control and not donate sperm during the study and for 90 days after receiving the last dose of study drug.
排除标准
- •Patients who have reported AEs which would prevent transfer to this study from the preceding study (JNS001-JPN-A01)
- •Patients who had been judged ineligible as patients for this study by investigator or subinvestigator
研究组 & 干预措施
001
JNS001 18 mg 27 mg and 36 mg tablets (18-72 mg/day) once daily for 48 weeks
干预措施: JNS001 (Drug)
结局指标
主要结局
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
时间窗: Throughout the study period (Month 12)
次要结局
- Change in DSM-IV Total ADHD symptoms scores (18 items) of the investigator-rated CAARS-O: SV from baseline of the preceding study (JNS001-JPN-A01) to each visit and to endpoint(Baseline to titration visits (Week 1-4) and to months 2-12 or discontinuation)
- Change in total score of Q-LES-Q-SF from baseline of the preceding study in the scores of the Q-LES-Q-SFat each visit and endpoint(Baseline to months 1-12 or discontinuation)
- Change in the scores of the CAARS-S: SV from baseline of the preceding study to each visit and to endpoint(Baseline to months 1-12 or discontinuation)
- Change in the scores of the CGI-S from baseline of the preceding study in the scores of the CGI-S at each visit and endpoint(Baseline to titration visits (Week 1-4) and to months 2-12 or discontinuation)