ACTRN12624000888561尚未招募1 期
A pilot study to investigate the effect of Cannabidiol on quality of life and beyond-seizure outcomes in children and adults with Developmental and Epileptic Encephalopathy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 20
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
- 2 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1.Has a documented clinical diagnosis of Dravet syndrome, Lennox-Gastaut syndrome as confirmed by the Pharmaceutical Benefits Scheme (PBS), or other developmental and epileptic encephalopathy ß.
- •2.Male or female (non-pregnant, non-lactating female) aged 2 years € to 65 years old.
- •3.Have countable motor seizures *, defined as:
- •-an average of greater than or equal to (>=) 2 per month during the past 3 months, based on the Study Doctor's assessment
- •-and a monthly average of >=1 per month during the Baseline Period, based on the seizure diary record, documented by caregiver report or Study Doctor medical notes.
- •4.Subjects can be taking 1 and no more than 3 concomitant antiseizure medications (ASMs) a. All doses must be stable for at least 4 weeks before screening and expected to be maintained throughout the study (until the end of the treatment period)
- •5.The Participant/parent/caregiver is able and willing to complete study visits, complete the questionnaires, record concomitant medications, and take study drugs as instructed.
- •6.For participants with G-tube/Percutaneous endoscopic gastrostomy (PEG) tube, G-tubes/PEG tubes should have been placed and been functioning for at least 3 months before screening.
- •* drop seizures, tonic-clonic, tonic, bilateral clonic, atonic, myoclonic-atonic, myoclonic-tonic-clonic, focal seizures with bilateral hyperkinetic motor features
- •a Epilepsy surgery is allowed and will not be counted as a concomitant ASM. A ketogenic diet is allowed and will not be counted as a concomitant ASM. The subject must be on a stable dietary regimen that produces ketosis for at least 6 weeks before screening and is expected to be maintained throughout the study.
- •ß CDKL5 Deficiency Disorder, SCN2A, SYNGAP1, West Syndrome, STXBP1, Ring20 Chromosome disorder, Rett Syndrome and DEPDC5.
- •€ The minimum age is due to the recommended age limit for using the portable electroencephalogram (EEG) device. Subjects between the ages of 2-6 years are eligible if their parent/guardian can provide an EEG completed in the last 6 months at the Baseline and the end of the trial.
排除标准
- •1.Seizures secondary to an infection, neoplasia, demyelinating disease, degenerative neurological disease, or central nervous system disease deemed progressive, metabolic illness, or progressive degenerative disease.
- •2.History or presence of any significant medical or surgical condition other than a DEE
- •3.History of jaundice which lasts longer than 1 week will require exclusion of hepatic disease before entering the study.
- •4.Subjects who are known to have a terminal illness.
- •5.Any clinically significant laboratory abnormalities or clinically significant abnormalities on pre-study physical examination, vital signs, or ECG that in the judgment of the Study Doctor indicate a medical problem that would preclude study participation.
- •6.Subjects who are planning to begin to follow a ketogenic or other specialized dietary therapy during the study.
- •7.Exposure to any other investigational drug or device within 5 half-lives or 30 days before screening (Visit 1), whichever is longer or plans to participate in another drug or device trial at any time during the study.
- •8.Concurrent enrolment in any other type of medical research judged by the Study Doctor not to be scientifically or medically compatible with this study.
- •9.Subjects using felbamate who have presented with clinically significant abnormalities and/or hepatic dysfunction during felbamate treatment, and subjects who have taken felbamate for less than 6 months before screening.
- •10.Subjects who are currently taking adrenocorticotropic hormone.
- •11.Subjects who did not tolerate Cannabidiol when taken previously or were allergic to sesame seed/oil.
- •12.Subjects who have a Vagal Nerve Stimulator (VNS) device. µ
- •µ Subjects with a VNS can be eligible if an EEG can be provided to the study doctor at the beginning and the end of the study.
研究者
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