An Open-label Extension Study of the Safety and Tolerability of Memantine in Pediatric Patients With Autism
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 19
- 主要终点
- Number of Patients Who Experienced a Treatment-emergent Adverse Event (TEAE)
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety and tolerability of memantine in the treatment of autism in pediatric patients.
详细描述
This is a 48-week multicenter extension study comprised of a 6-week double-blind dose-titration period followed by a 42-week open-label maintenance period.
In the Forest autism trials conducted in children ages 6-12, dosing with an extended release formulation of memantine was weight-based. These weight based dose limits were selected to ensure exposure in terms of area under the curve (AUC) was less than the predefined limit of 2100 ng∙h/mL that represented a 10-fold lower exposure than observed at the NOAEL (No observed adverse effect level) of 15 mg/kg/day in juvenile rats.
The weight-based dose limits in these studies were as follows:
- Group A: ≥ 60 kg; max 15 mg/day
- Group B: 40-59 kg; max 9 mg/day
- Group C: 20-39 kg; max 6 mg/day
- Group D: < 20 kg; max 3 mg/day
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
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed lead-in study MEM-MD-57A (NCT00872898)
- •A knowledgeable caregiver capable of providing reliable information about the patient's condition, able to attend all clinic visits with the patient
排除标准
- •Patients with a concurrent medical condition that might interfere with the conduct of the study
研究组 & 干预措施
Memantine
Once daily oral administration of memantine for 48 weeks: 6-week double-blind dose-titration period followed by a 42-week maintenance period.
干预措施: Memantine HCl (Drug)
结局指标
主要结局
Number of Patients Who Experienced a Treatment-emergent Adverse Event (TEAE)
时间窗: From Visit 1 (Week 1) to 30 days after Visit 8 (Week 48)
Number of patients who experienced one or more TEAEs during the study
次要结局
未报告次要终点