CTIS2023-503709-12-00招募中1 期
Open-label pilot study to assess the efficacy and safety of Cannabidiol oral solution as an adjunctive treatment for children and young adults with rare disease-associated severe epilepsy - CBD_RE
Azienda Ospedaliero Universitaria Meyer IRCCS0 个研究点目标入组 30 人开始时间: 2023年3月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 64（—）
- 性别
- All
入选标准
- •Male or female aged 2-25 years as of the day of the Screening Visit;, Subject with rare disease-associated severe epilepsy. Subject has been certified by the National Health System as affected by a rare disease listed in https://www.malattierare.gov.it, Patient has severe epilepsy, with at least 4 motor (generalized, focal, or both) seizures per month during baseline period, despite 2 or more current or prior ASMs;, Previous treatment with at least 2 ASMs and currently taking at least 1 other ASMs or between one and four ASMs, with a stable antiseizure treatment for the previous 4 weeks (including ketogenic diet and vagal nerve stimulation);, Subject’s parent/caregiver has been informed of the nature of the study and informed consent has been obtained from the legally responsible parent/guardian;, Subject’s parent/caregiver is willing and able to be compliant with diary completion, visit schedule and study drug accountability in the opinion of the investigator., Surgical treatment for the epilepsy has failed or cannot be pursued
排除标准
- •Age <2 years, Inadequate supervision by parents and/or caregivers as judged by the investigator, Subject has been part of a clinical trial involving another investigational medicinal product in the previous six months, Patients with LGS, DS or TSC, Current or past use of recreational or medicinal cannabis, or cannabinoid-based medications, within the three months prior to screening, Patients with previous history of suicidal behaviour and ideation or at high suicidal risk based on clinical assessment and administration of the Columbia Suicide Severity Rating Scale (for patients 6 years of age, when appropriate otherwise, clinical judgment will be used), Female patients who are pregnant and female of childbearing potential unless willing to ensure the use of a highly effective method of birth control during the study and for three months thereafter, Known hypersensitivity to CBD or any of the excipients in the study formulation, Progressive neurological disease, Clinically significant unstable medical conditions other than epilepsy 5.Any other significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, may influence the result of the study, or affect the patient’s ability to participate in the study, Impaired hepatic function at screening defined as any of the following: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of normal (ULN) and total bilirubin (TBL) greater than 2 times the ULN, Subject taking more than four concurrent ASMs, corticotropins in the six months prior to screening, felbamate for less than one year prior to screening
研究者
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