ACTRN12624000948594招募中2 期
Efficacy And Withdrawal Symptoms in Transition Between CBDV to CBD in Children with Rett Syndrome and Refractory Epilepsy
Sydney Children's Hospital Network0 个研究点目标入组 3 人开始时间: 2024年8月5日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 12 Years 至 o limit（—）
- 性别
- Female
入选标准
- •1.Involvement in previous phase I trial of CBDV in Rett Syndrome.
- •2.Rett syndrome with known MECP2 mutation.
- •3.Refractory epilepsy (having failed an adequate trial of at least two standard anti-seizure medications).
- •4.Patient and caregiver willing and able to comply with all trial requirements.
- •5.All medications and interventions stable for four weeks prior to screening and patient / caregiver willing to maintain stable regimen throughout trial.
排除标准
- •1.Another significant neurological diagnosis (history of traumatic brain injury, metabolic disease, or infection).
- •2.Significant non-neurological diagnosis (e.g., severe cardiac or respiratory disease).
- •3.Pre-existing abnormalities of full blood count, electrolytes, coagulation, hepatic function or enzymes considered clinically significant as judged by the investigator (e.g., WCC < 4, platelets < 60 000, ANC < 1, ALT or AST > 2 times upper limit normal).
- •4.Clinically significant ECG abnormality (e.g., QTc > 460 msec, PR > 0.2 sec).
- •5.Patient currently using or has used other cannabinoid products other than CBDV and unwilling to abstain for duration of the trial.
- •6.Female subjects who are pregnant will be excluded. A negative serum pregnancy test is required at screening. If female subjects become pregnant during the study, they must inform the investigator, and consult an obstetrician.
- •7.Known allergy to or any component of either CBDV, CBD or any cannabinoid.
- •8.Patient has any other significant disease or disorder which in the opinion of the investigator, may put the patient at risk or influence the result of the trial or the patient’s ability to participate in the trial.
- •9.Any abnormalities identified following a physical examination of the patient that, in the opinion of the investigator, would jeopardize the safety of the patient if they took part in the trial.
- •10.Patient is taking more than four other concurrent anti-epileptic drugs.
- •11.Patient has taken felbamate in year prior to screening.
研究者
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