NCT02140112终止2 期
A RANDOMIZED, DOUBLE-BLIND, PHASE 2A CROSSOVER STUDY TO ASSESS THE SAFETY AND EFFICACY OF TRICHURIS SUIS OVA FOR THE TREATMENT OF AUTISM SPECTRUM DISORDER
Coronado Biosciences, Inc.5 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2014年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 23
- 试验地点
- 5
- 主要终点
- Change from Baseline in Aberrant Behavior Checklist - Irritability (ABC-I) at 16 weeks
研究概览
简要总结
This is a randomized, double-blind, 2-arm, placebo-controlled crossover study in pediatric patients with autism spectrum disorder with all patients receiving 16-weeks of TSO treatment and 16 weeks of placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients, 5 to 17 years of age
- •Patients must fulfill DSM-V diagnostic criteria for autism spectrum disorder ascertained at screening, using a clinical review confirmed by the Autism Diagnosis Observation Schedule - Second edition (ADOS-2)
- •Written informed consent from parent(s) or legal guardian(s) with sufficient intellectual capacity to understand the study and support patients' adherence to the study procedures must be obtained for patients who are not emancipated. In accordance with Institutional Review Board (IRB) requirements, the patient will complete an informed assent when developmentally appropriate, to participate in the study before conduct of any study-specific procedures.
- •Patients are able and willing to swallow study medication suspension.
排除标准
- •Known diagnosis of syndromal form of Autism (e.g. Rett Syndrome, Childhood Disintegrative Disorder, Fragile X Syndrome, etc.)
- •Patients who cannot discontinue anti-psychotic medication
- •Patients with current active seizure disorder or who have had a seizure within the last 6 months prior to screening
- •Female patient who is pregnant or breastfeeding or wishing to become pregnant during study participation or unwilling to use birth control.
- •Patients who have received helminthic treatment
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo 8 doses every 2 weeks
干预措施: Placebo (Other)
Trichuris suis ova
Active Comparator
TSO 2500 x 2 doses every 2 weeks followed by TSO 7500 x 6 doses every 2 weeks
干预措施: Trichuris suis ova (Biological)
结局指标
主要结局
Change from Baseline in Aberrant Behavior Checklist - Irritability (ABC-I) at 16 weeks
时间窗: 36 weeks
次要结局
未报告次要终点
研究者
研究点 (5)
Loading locations...
相似试验
招募中
2 期
Efficacy, Safety and Pharmacokinetics of ES-481 in Adult Patients With Drug Resistant EpilepsyDrug Resistant EpilepsyNCT04714996ES Therapeutics Australia Pty Ltd24
已完成
2 期
A Study Of The Effects Of CB2 Compound Of GW842166 In Patients With OsteoarthritisOsteoarthritisNCT00479427GlaxoSmithKline1
已完成
2 期
A Study of CST-2032 and CST-107 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's or Alzheimer's DiseaseMild Cognitive ImpairmentDementiaNCT05104463CuraSen Therapeutics, Inc.64
终止
2 期
Bumetanide in Hypokalaemic Periodic ParalysisHypokalemic Periodic ParalysisNCT02582476University College, London12
已完成
2 期
Glucagon Ready-to-Use (RTU) for Prevention of Exercise-Induced Hypoglycemia During Aerobic Exercise in Adults With T1DHypoglycemiaNCT03841526Xeris Pharmaceuticals48