NCT00912691已完成3 期
A Phase III Open Label Extension Study of CM-AT in Children With Autism
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Curemark
- 入组人数
- 165
- 试验地点
- 19
- 主要终点
- Evidence of changes in behavior scales associated with the core symptoms of autism
研究概览
简要总结
The purpose of this study is to determine whether CM-AT is effective in treating the core symptoms of autism.
详细描述
Autism is currently a significant cause of disability in the pediatric population. CM-AT is based upon the observation that many children with autism do not digest protein. CM-AT is a proprietary enzyme that is designed as a powder taken three times a day. It is formulated to be released in the small intestine to enhance protein digestion thus increasing the availability of essential amino acids.
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
- 9 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets the current Diagnostic and Statistical Manual for Mental Disorders (DSM-IV-TR) diagnostic criteria for autistic disorder (AD)
- •Ongoing 00102 Protocol required completion of 00101 Protocol
- •Now recruiting subjects directly into 00102 Protocol
排除标准
- •Ongoing study required patients to be 3-8 years old weighing < 11kg (24.2 lbs.), and achieving ages 9-12 years old weighing < 22kg (48.4 lbs.).
- •Newly recruited subjects must be between ages 9 - 12 years old weighing < 22kgs (48.4 lbs.)
- •Demonstrated previous allergy to porcine (pork) products
- •Previous history of severe head trauma or stroke, seizure within one year of entering study or uncontrolled systemic disease
- •Diagnosis of: HIV, cerebral palsy, endocrine disorder, pancreatic disease
- •Within 30 days of starting the study, certain supplementation, chelation or dietary restriction (a 30 day washout period would be required for inclusion)
- •Any use of psychotropic medications, stimulants, or SSRI's must be discontinued for 30 days prior to entrance
研究组 & 干预措施
1
Experimental
CM-AT
干预措施: CM-AT (Drug)
结局指标
主要结局
Evidence of changes in behavior scales associated with the core symptoms of autism
时间窗: Baseline, 4, 8, 12, 16, 20, 24, 36, 60, 72, 84,96,108,120,132,144,156, 168, and 180 weeks
次要结局
- Other key measures of behavior and quality of life associated with autism(Baseline, 4, 8,12,16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, and 180 weeks)
研究者
研究点 (19)
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