NCT02783092进行中（未招募）3 期
A Double-blind, Randomized Placebo-controlled Trial to Evaluate Efficacy and Safety of Cannabidiol as an add-on Therapy for Treatment in Refractory Epileptic Crisis in Children and Adolescents
Antonio Waldo Zuardi1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2019年1月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Frequency of epileptic seizures
研究概览
简要总结
The purpose of this study is to assess the efficacy of the adjuvant use of cannabidiol administered twice daily in doses of 5-25 mg/kg/day through the proportion of responsive patients; that is, participants with at least 50% decrease in the frequency of epileptic seizures in the last month of the trial relative to baseline (pretreatment with AEDs only).
Primary end point(s): Rate of responsive patients; that is, participants with at least 50% decrease in the frequency of epileptic seizures in the last month of the trial relative to baseline (pretreatment with AEDs only).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 2 years to 18 years.
- •Diagnosis of treatment-resistant epilepsy according to the criteria of the International League Against Epilepsy (ILAE) (Kwan et al., 2010).
- •Participants with at least 4 epileptic seizures with intervals no longer than 21 days.
- •In treatment with up to 3 AEDs concomitantly and at stable doses for at least 1 month before the baseline assessment and expected to remain stable during the period of the trial. Vagus nerve stimulation (VNS) will be considered as an AED.
- •Availability of a legal guardian able to follow the protocol (e.g., understand and fill up diaries) and visitation and medication schemes, according to the decision of the investigator.
- •Availability of brain neuroimaging exams (magnetic resonance or computed tomography) collected within the last 5 years.
- •No significant comorbid conditions, according to medical decision, to other criteria in this Protocol, and to additional assessments: medical records, blood pressure, heart rate, and temperature measures, physical exam, ECG, EEG, and laboratory tests.
- •Women in reproductive age may be included as long as they are sexually abstinent or using effective contraceptive methods.
- •Participants and their legal guardians, when applicable, must sign an informed consent form approved by the local ethics committee.
排除标准
- •Occurrence of simple partial seizures (preserved consciousness) only, with no motor symptomatology.
- •History or presence of pseudoseizures.
- •History of suicide attempt.
- •History of major depression.
- •Pregnancy.
- •Drug use.
- •Hypertension.
- •Participants with severe dysphagia and no gastric or nasogastric tubes.
- •Current treatment with drugs that may significantly affect the metabolism of CBD, except AEDs if stable for at least 1 month before the screening interview.
- •Presence of any clinical or neuroimaging finding suggestive of brain disorders, brain tumors, or metabolic or neurodegenerative diseases of rapid progression.
- •Presence of acute and clinically significant diseases as assessed by a medical investigator, such as kidney, liver, urinary, bowel, or respiratory infections.
- •Presence of known chronic and clinically significant diseases as assessed by a medical investigator and which may interfere with participation in the trial or pose safety risks for the participant.
- •History of liver, kidney, lung, hematological, heart, or psychiatric diseases that may affect the volunteers' health or participation in the trial.
- •Hypotension or hypertension with any etiology and requiring pharmacological management.
- •History of surgeries that may affect the volunteers' health and/or participation in the trial.
- •Regular or intermittent use of marijuana over the 60 days preceding the baseline assessment.
- •Regular or intermittent treatment with CBD over the 60 days preceding the baseline assessment.
- •History of allergies or idiosyncratic reactions to Cannabis sativa derivatives or components of the pharmaceutical formulation.
- •Clinically significant ECG alterations as judged by a medical investigator.
- •Participation in other clinical trials within less than 3 months before the baseline assessment.
- •Donation or loss of 450 mL or more of blood within 90 days before the baseline assessment.
- •Impaired liver function: AST, ALP, alkaline phosphatase and γGT values more than 3 times above the upper limit of the reference value. Results of γGT values 3 times above the upper limit will only be accepted if attributable to liver enzymatic induction caused by concomitant treatment with AEDs and with levels of other liver enzymes lower than 3 times the upper limit of the reference range.
- •Participants with clinically significant discrepancies from the reference ranges of the following laboratory tests: creatinine clearance < 50 ml/min, platelets < 100.000/μL, and neutrophils < 1.800/μL.
研究组 & 干预措施
Cannabidiol
Experimental
Concentration unit: 200mg/ml; 5 - 25 mg/Kg/day ; Oral solution
干预措施: Cannabidiol (Drug)
Placebo
Placebo Comparator
Oral solution
干预措施: Placebo (Drug)
结局指标
主要结局
Frequency of epileptic seizures
时间窗: 17 th week
次要结局
未报告次要终点
研究者
Antonio Waldo Zuardi
MD, PhD, Professor
University of Sao Paulo
研究点 (1)
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