NCT02649959进行中（未招募）3 期
An Open-Label Extension Study of CM-AT for the Treatment of Children With Autism With All Levels of Fecal Chymotrypsin
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Curemark
- 入组人数
- 405
- 试验地点
- 31
- 主要终点
- Aberrant Behavioral Checklist: Subscale of Irritability / Agitation (ABC-I) at fecal chymotrypsin (FCT) levels less than or equal to 12.6
研究概览
简要总结
This is a Phase III, open label extension study evaluating the continued safety and efficacy of CM-AT in pediatric patients with autism with all levels of fecal chymotrypsin.
详细描述
Autism is clearly a significant cause of disability in the pediatric population. Treatment is based on the observation that many children with autism do not digest protein. CM-AT is a proprietary enzyme that is designed as a granulated powder taken three times daily.
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
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 3 and 8 years, inclusive, at the time of signing informed consent/assent in Sponsor 00103 Study
- •Completion of the Sponsor's 00103 Study who continue to meet eligibility requirements
- •Currently in the 00102 open label study and continue to meet eligibility requirements
- •Subjects who initially qualified for 00103 screening, who subsequently failed Baseline entrance criteria for randomization (@Visit 1) Baseline assessment of the ABC eligibility requirement who continue to meet eligibility requirements
- •Up to 20 subjects 9-17 years of age who directly enroll into this study, who meet the current Diagnostic and Statistical Manual for Mental Disorders (DSM-IV-TR) diagnostic criteria for Autistic Disorder (AD), screened by the SCQ and confirmed by the ADI-R
排除标准
- •Patient weighing < 13kg
- •Allergy to porcine products
- •Previous sensitization or allergy to trypsin, pancreatin, or pancrelipase
- •History of severe head trauma, as defined by loss of consciousness or hospitalization, skull fracture or stroke.
- •Seizure within the last year prior to enrollment, or the need for seizure medications either at present or in the past.
- •Evidence or history of severe, moderate or uncontrolled systemic disease
- •Ongoing dietary restriction for allergy or other reasons except nut allergies. Lactose free is allowable but not dairy free.
- •Inability to ingest the study drug / non-compliance with dosing schedule.
- •Inability to follow the prescribed dosing schedule.
- •Use of any stimulant or non-stimulant medication or medications given for attention deficit hyperactivity disorder (ADHD) must be discontinued 5 days prior to the initial randomized study period.
- •Subjects taking an selective serotonin reuptake inhibitor (SSRI) must be on a stable dose for a minimum of 30 days prior to entering the study.
- •History of premature birth <35 weeks gestation.
- •Prior history of stroke in utero or other in utero insult.
研究组 & 干预措施
Open Label
Experimental
CM-AT
干预措施: CM-AT (Drug)
结局指标
主要结局
Aberrant Behavioral Checklist: Subscale of Irritability / Agitation (ABC-I) at fecal chymotrypsin (FCT) levels less than or equal to 12.6
时间窗: Change from Baseline to each post-baseline visit, through study completion Week 72.
次要结局
- Aberrant Behavior Checklist: Subscale of Lethargy / Social Withdrawal (ABC-L) at fecal chymotrypsin (FCT) levels less than or equal to 12.6(Change from Baseline to each post-baseline visit, through study completion Week 72.)
研究者
研究点 (31)
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