A Long-Term, Open-Label, and Single-Arm Study of NRP104 30 mg, 50 mg, or 70 mg Per Day in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 349
- 试验地点
- 45
- 主要终点
- Change in ADHD-RS-IV Total Score From Baseline at Up to One Year
研究概览
简要总结
The purpose of this study is to assess the long-term safety and efficacy of three NRP104 doses of 30 mg, 50 mg, or 70 mg, administered at the same time daily, in the treatment of adults with ADHD.
详细描述
This is a multi-center, open-label, and single-arm study to assess the safety of three NRP104 doses (30 mg, 50 mg, or 70 mg per day) for up to one (1) year in the treatment of adults with ADHD. Subjects who were randomized and met all inclusion/exclusion criteria in Protocol NRP104.303 are eligible for participation in this protocol. The study will consist of three periods: a screening/baseline period, a 4-week dose titration, and a long-term maintenance of up to 11 months. There are three possibilities for subjects that rollover from the NRP104.303 protocol. They are:
Subjects that rollover at the final visit of the NRP104.303 study (on the same day):
The screening and baseline procedures from this open label study will coincide with the final study visit of Protocol NRP104.303. Subject data from final study visit will be transferred and utilized for the open label study. On this same day, the subject will be consented for NRP104.304, inclusion/exclusion criteria will be assessed, the subject will be enrolled, and study medication will be dispensed.
Subjects that rollover not on the same day but within seven days of the NRP104.303 study:
If the subject returns to enroll into the NRP104.304 study within seven days of the final NRP104.303 study visit and has not taken any excluded medications for which a washout is required, the final study visit procedures and data from the NRP104.303 study will be transferred and utilized for the screening and baseline visit procedures of this study, where applicable. When the subject returns to the site, they will be consented, inclusion and exclusion criteria will be assessed, the subject will be enrolled, and study medication will be dispensed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be 18-55 years of age, inclusive, at the time of consent of the NRP104.303 study.
- •Subject must have been randomized and must have met all inclusion/exclusion criteria in the NRP104.303 study.
- •Subject must be male or non-pregnant female. Females of childbearing potential (FOCP) must comply with contraceptive restrictions noted in the protocol.
- •Subject must have a satisfactory medical assessment with no clinically significant or relevant abnormalities as determined by medical history, PE, clinical and laboratory evaluation.
- •In the opinion of the investigator, the subject understands and is able, willing, and likely to fully comply with the study procedures and restrictions.
- •Subject must have given written, personally signed and dated informed consent to participate in the study in accordance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines and applicable regulations before completing any study specific procedures.
- •Subject experienced no adverse events in a previous study of NRP104 or elsewhere that would preclude continued exposure to NRP104.
排除标准
- •Subject has any concurrent chronic or acute illness or unstable medical condition that could confound the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol. Subjects who have a history of mental retardation or a severe learning disability are excluded.
- •Subject has a known cardiac structural abnormality or any other condition that may affect cardiac performance.
- •Subject has any clinically significant ECG or laboratory abnormality known to the investigator prior to dispensation of study medication.
- •Subject has a resting sitting systolic blood pressure or diastolic blood pressure deemed clinically significant by the investigator.
- •Subject has used any prohibited prescription medication except for medications used to treat ADHD within 30 days of screening visit. Hormonal contraceptives are acceptable.
- •Subject has a positive urine drug result at Screening (with the exception of subject's current stimulant therapy, if any).
- •Subject has taken an investigational drug or taken part in a clinical trial within 30 days prior to Screening (except for participating in an NRP104 study).
- •The female subject is pregnant or lactating.
研究组 & 干预措施
1
干预措施: Vyvanse (lisdexamfetamine dimesylate), NRP104 (Drug)
结局指标
主要结局
Change in ADHD-RS-IV Total Score From Baseline at Up to One Year
时间窗: up to one year
Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.
次要结局
- Number of Participants With Improvement on CGI-I(Up to 1 year)
- Change in PSQI Total Score From Baseline at Up to One Year(up to 1 year)