A single-centre, open-label pilot study to assess the efficacy and safety of CBD oral solution as an adjunctive treatment for pediatric subjects with Developmental and Epileptic Encephalopathy - CBD_DEE

IRCCS, OSPEDALE PEDIATRICO BAMBINO GESÙ DI ROMA0 个研究点目标入组 20 人开始时间: 2021年5月24日最近更新: 2021年8月30日

适应症

试验速览

暂无简介。

•oMale or female;
•oAged between 2 and 7 years;
•oA documented history of DEE [7];
•oCurrently taking at least 1 other AED between one and four AEDs, with a stable antiseizure treatment for the previous 4 weeks (including ketogenic diet and vagus nerve stimulation);
•oInadequately seizure control with 2 or more current or prior AEDs;
•oWritten informed consent provided by the participant and/or parent(s)/caregiver(s).
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•oClinically significant unstable medical or psychiatric conditions that may place patient’s safety at risk;
•oClinically significant liver disease or serum aminotransferase (ALT or AST) >3 times the upper limit of the normal range or total bilirubin >2 times the upper limit of the normal range or international normalized ratio (INR) >1.5;
•oKnown or suspected intolerance or hypersensitivity to cannabinoids or any of the excipients of the medicinal product such as sesame oil;
•oCurrent use of ACTH or other systemic steroids;
•oCurrent use (or use in the previous 2 months) of medicinal cannabis, or synthetic cannabinoid-based medications;
•oInadequate supervision by parent(s)/caregiver(s) in the judgment of investigators
•oStable felbamate dosing = 1 year;
•oSubjects who have been part of a clinical trial involving another investigational product in the previous six months;
•oSubjects with severe renal impairment: estimated glomerular filtration rate (eGFR) calculated as crCL < 30 ml/min, according to Schwartz equation.

发起方

IRCCS, OSPEDALE PEDIATRICO BAMBINO GESÙ DI ROMA