NCT00881452已完成3 期
A Phase III Randomized Double Blind Placebo Controlled Trial 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
- 182
- 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 safe and effective in treating the core symptoms of autism.
详细描述
Autism is currently a significant cause of disability in the pediatric population. Treatment 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.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 8 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)
排除标准
- •Patient weighing < 11kg (24.2 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)
- •Use of of any stimulant medication must be discontinued 5 days prior to entering the study.
- •Subject must have a stable dose of SSRI's for at least 30 days.
研究组 & 干预措施
CM-AT
Active Comparator
CM-AT (Luminenz-AT)- 900mg CM-AT, pancreatic enzyme concentrate (720mg)
干预措施: CM-AT (Drug)
Placebo
Placebo Comparator
Placebo 900mg (Sucanate (98% w/w), Citric Acid (2% w/w)
干预措施: Placebo (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, 14 days, 30 days, 60 days, 90 days
次要结局
- Other key measures of behavior and quality of life associated with autism(Baseline, 14 days, 30 days, 60 days, 90 days)
研究者
研究点 (19)
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