A Randomized, Double-Blind, Sparing-effect Placebo Controlled, With Cross-over Study to Evaluate the Safety, Tolerability and Efficacy of SCI-210 in Children With Autism Spectrum Disorder (ASD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- SciSparc
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evaluation of the efficacy of SCI-210 in the treatment of Autism Spectrum Disorders (ASD)
研究概览
简要总结
To evaluate the safety and efficacy of SCI-210 in the treatment of Autism Spectrum Disorders (ASD)
详细描述
The innovative compound SCI-210 consists of CBD oil combined with CannAmide (PEA formulation) using the "entourage effect" to enhance efficacy of CBD. It is believed that PEA potentiates anandamide responses in non-vascular tissues. This effect is called "entourage effect". The "entourage effect" can be achieved by enhancing the action of endogenous anandamide through an increase in the affinity for receptors and/or a decrease in enzymatic degradation of anandamide (primarily by fatty acid amide hydrolase, FAAH). Thus, the combination of CBD oil with PEA is believed to be more effective than CBD oil alone, while AEs are not increased by the addition of the natural substance PEA.
SCI-210 has not been tested in clinical trials before, but anecdotal evidence of combined use of CBD and CannAmide in ASD patients has been accumulated in recent months. The evidence suggests the beneficial effects of the combination in alleviating ASD symptoms with no reported adverse events associated with the treatment.
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 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged between 5 and 18 years of age (inclusive)
- •Diagnosis of ASD confirmed by the ADOS-2 and DSM-5 criteria
- •Moderate or greater behavioral problems as measured by a rating of moderate or higher (≥4) on the Clinical Global Impression-Severity (CGI-S)
- •Presence of a parent/legal guardian who is able to consent for their participation and completes assessments regarding the child's development and behavior throughout the study
- •Patients eligible for cannabis treatment as regulated by the Israeli Ministry of Health, as out lined in the Medical Cannabis unit circular on Licenses for cannabis use, Procedure number 106, version 5 dated Jan 2021
排除标准
- •Children who are already receiving cannabis, antipsychotic drugs, or stimulants.
- •Children with heart, liver, renal or hematological disorders.
- •History of active seizure disorder or epilepsy; patients who are seizure free for more than 3 years can take part in the study
- •Exposure to any investigational agent in the 30 days prior to trial onset.
- •A current psychiatric diagnosis of bipolar disorder, major depressive disorder (MDD), psychosis, schizophrenia, or post-traumatic stress disorder (PTSD)
- •Subjects who have had changes in non-exclusionary psychotropic medications within 4 weeks of initiation of trial.
- •Allergic to cannabinoids or PEA tablet components.
- •History of substance abuse (including alcohol abuse or dependence) or laboratory evidence of drug abuse on the Visit 1 drug-screening panel.
- •Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he or she were to participate in the study.
研究组 & 干预措施
SCI-210
Oral CBD oil plus pills of CannAmide (palmitoylethanolamide (PEA) 400 mg twice daily
干预措施: SCI-210 (Drug)
CBD oil
CBD- active CBD oil with twice daily and CannAmide Placebo pills matched in appearance and taste to CannAmide active pill.
干预措施: Oral CBD oil (Drug)
结局指标
主要结局
Evaluation of the efficacy of SCI-210 in the treatment of Autism Spectrum Disorders (ASD)
时间窗: 24 weeks
Evaluation of the efficacy of SCI-210 in the treatment of Autism Spectrum Disorders (ASD) throughout the 24 week treatment period. The primary outcome measures of the study will be the Aberrant Behavior Checklist-Community (ABC-C) parent questionnaire performed by a clinician. These will be completed at the beginning (Time 0), middle (4 weeks) and end (8 weeks) of each stage. Efficacy of treatment will be evaluated by comparing the change in ABC-C scores during the different periods of the study between the two treatment and control groups.
Evaluation of the safety of SCI-210 in the treatment of Autism Spectrum Disorders (ASD)
时间窗: 24 weeks
Evaluation of the safety of SCI-210 in the treatment of Autism Spectrum Disorders (ASD) throughout the 24 week treatment period. Adverse effects will be assessed using an adverse effects checklist (AEC) containing 19 items from the Liverpool Adverse Events Profile (LAEP) in addition to 15 items that have been used previously to assess side effects of CBD. These will be compared between the groups. Dropout rates from study will also be compared between these groups.
次要结局
- Evaluate the safety of SCI-210 in children with ASD.(24 weeks)
- Assess the efficacy of SCI-210 in reducing disruptive behaviors among children with ASD(20 weeks)
- Assess the efficacy of SCI-210 in reducing ASD symptoms among children with ASD.(20 weeks)
- Assess the efficacy of SCI-210 in improving language abilities among children with ASD(20 weeks)
- Assess the efficacy of SCI-210 in reducing sleep problems among children with ASD(20 weeks)
- Evaluate the tolerability of SCI-210 in children with ASD.(24 weeks)
- Assess the efficacy of SCI-210 in improving adaptive behaviors among children with ASD(20 weeks)
- Assess the effects of SCI-210 on eye tracking measures when viewing social movies.(20 weeks)