Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and Safety of Donepezil Hydrochloride in Preadolescent and Adolescent Children With Attention Impairment Following Cancer Treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change From Baseline in the Test of Variables in Attention-Continuous Performance Test (TOVA-CPT) "D-prime" Standard Score (SS) at Week 12
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety and tolerability of donepezil in children with persistent attention impairment that is present at least 12 months after the completion of cancer treatment.
详细描述
This is a double-blind, placebo-controlled, parallel group study in pediatric subjects who have persistent attention impairment following treatment for cancer. This trial has three phases: (1) pre-randomization to establish eligibility, (2) a 12-week, double-blind, placebo-controlled, parallel-group phase with dose escalation based on body weight, (3) a 12-week, blinded extension phase during which all subjects will receive active drug.
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)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Subjects who meet any of the following criteria will be excluded from the study:
- •Inability to perform the required tests (for example, because of aphasia, motor deficits affecting the dominant hand, or mental retardation).
- •Motor coordination not sufficient, according to tests to be conducted at the time of screening.
- •Recurrence of cancer. If this happens, the subject will have to withdraw from the study.
- •Mental retardation/developmental disability.
- •Certain medications, such as methylphenidate, are not allowed during the study.
- •Major depression.
- •Problems with the digestive tract that could affect the subject's ability to absorb the study drug.
- •Hypersensitivity to a chemical class known as piperidine derivatives.
- •Certain other medical conditions as determined by clinical staff.
- •Alcoholism, drug abuse, or organic brain disease other than that caused by the cancer or its treatment.
- •Pregnancy, nursing, or unwillingness to undergo pregnancy testing if requested by clinical staff.
- •Pregnancy, lactation or plans to become pregnant, or unwilling to take a screening Beta-human chorionic gonadotropin (ßhCG) test if a female >10 years of age.
- •If sexually active, unwillingness to use birth control (males and females).
- •Plans for certain types of elective surgery that would occur while the study is in progress.
- •Plans for travel or other events that would interfere with the study schedule.
- •Active treatment with another investigational drug within 3 months of the screening visit.
研究组 & 干预措施
1
干预措施: Donepezil hydrochloride (Drug)
2
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the Test of Variables in Attention-Continuous Performance Test (TOVA-CPT) "D-prime" Standard Score (SS) at Week 12
时间窗: Baseline and Week 12
TOVA-CPT test has a standardized computer game-like format that tests attention and simple impulse control. It precisely measures a person's reaction time to clicking on correct targets versus incorrect targets. Scores are based on the number of "Hits" (correct responses), omission errors (failure to respond), commission errors/"False Alarms" (incorrect responses), response time, and sensitivity ("d-prime"). "D-prime" a dimensionless statistics is a measure of distractibility and reflects how well a person reacts correctly versus incorrectly. A higher value of "d-prime" is reached by having more "Hits" (correct response) and fewer "False Alarms" (incorrect response). Analysis was based on three factors: the "d-prime" standard score, reaction time variability standard score, and response time standard score. Standard scores less than or equal to 80 were significant for an attention deficit disorder. Standard scores greater than 80 were not significant for an attention deficit disorder.
次要结局
- Change From Baseline in the TOVA-CPT "D-prime" Standard Score (SS) at Week 6(Baseline and Week 6)
- Change From Baseline in the Reaction Time Variability Standard Score (RTVSS) and Response Time Standard Score (RTSS) at Weeks 6 and 12(Baseline, Weeks 6 and 12)
- Change From Baseline in the Global Executive Composite Score, Behavioral Regulation Index, Metacognition Index, and Working Memory Subscale(Baseline and Week 12)