NL-OMON44663已完成3 期
A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome. - GWEP1424
GW Research Ltd.0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 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
- 2 至 17（—）
入选标准
- •Patient and/or parent(s)/legal representative must be willing and able
- •to give informed assent/consent for participation in the study.;• Patient and their caregiver must be willing and able (in the
- •investigator's opinion) to comply with all study requirements.;• Patient must be male or female aged between two and 18 years
- •(inclusive).;• Patient must have a documented history of DS which is not completely
- •controlled by current AEDs.;• Patient must be experiencing four or more convulsive seizures (i.e.,
- •tonic-clonic, tonic, clonic, atonic seizures) during the first 28 days of the
- •baseline period.;• Patient must be taking one or more AEDs at a dose which has/have
- •been stable for at least four weeks.;• All medications or interventions for epilepsy (including ketogenic diet
- •and vagus nerve stimulation [VNS]) must have been stable for four
- •weeks prior to screening and patient and caregiver are willing to
- •maintain a stable regimen throughout the study. The ketogenic diet and
- •VNS treatments are not counted as an AED.;• Patient and/or parent(s)/legal representative is willing to allow his or
- •her primary care practitioner and consultant to be notified of
- •participation in the study.;• Patient has completed their Interactive Voice Response System (IVRS)
- •telephone diary on at least 25 days of the baseline period; patients who
- •are non-compliant will be deemed ineligible to continue.
排除标准
- •Patient has clinically significant unstable medical conditions other than
- •epilepsy.;• Patient has had clinically relevant symptoms or a clinically significant
- •illness in the four weeks prior to screening or randomization, other than
- •epilepsy.;• Patient has clinically significant abnormal laboratory values, in the
- •investigator's opinion, at screening or randomization.;• Patient has clinically relevant abnormalities in the ECG measured at
- •screening or randomization.;• Patient has any concurrent cardiovascular conditions which will, in the
- •investigator's opinion, interfere with the ability to assess their ECGs.;• Patient has a history or presence of alcohol or substance abuse within
- •the last two years prior to the study or daily consumption of five or more
- •alcohol-containing beverages.;• Patient is currently using, or has in the past used, recreational or
- •medicinal cannabis, or synthetic cannabinoid-based medications
- •(including Sativex®) within the three months prior to study entry.;• Patient is unwilling to abstain from using recreational or medicinal
- •cannabis, or synthetic cannabinoid based medications (including
- •Sativex®) during the study.;• Patient has a history of symptoms (e.g., dizziness, light-headedness,
- •blurred vision, palpitations, weakness, syncope) related to a drop in
- •blood pressure due to postural changes.;• Patient has ingested alcohol in the 24-hour period prior to the first
- •study visit and/or is unwilling to abstain from drinking alcohol
- •throughout the treatment period.;• Patient has any known or suspected hypersensitivity to cannabinoids
- •or any of the excipients of the IMPs (e.g., sesame oil).;• Female patient is of child bearing potential or male patient's partner is
- •of child bearing potential; unless willing to ensure that they or their
- •partner use highly effective contraception for the duration of the study
- •and for three months thereafter. Highly effective methods of
- •contraception are defined as those, alone or in combination, that result
- •in a low failure rate (i.e., less than 1% per year) when used consistently
- •and correctly. Such methods include hormonal contraceptives,
- •intrauterine devices/hormone-releasing systems, bilateral tubal
- •occlusion, vasectomized partner or sexual abstinence.;• Female patient who is pregnant (positive pregnancy test), lactating or
- •planning pregnancy during the course of the study and for three months
- •thereafter.;• Patient has been part of a clinical trial involving another IMP in the
- •previous six months.;• Patient is taking felbamate and they have been taking it for less than
- •one year prior to screening.;• 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.;• Patient has significantly impaired hepatic function at screening (Visit
- •1) or randomization (Visit 2), defined as any of the
- •- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
- •>5 x upper limit of normal (ULN).
- •- ALT or AST >3 x ULN and (total bilirubin [TBL] >2 x ULN or
- •international normalized ratio [INR] >1.5).
- •- ALT or AST >3 × ULN with the presence of fatigue, nausea, vomiting,
- •right upper quadrant pain or tenderness, fever, rash, and/or
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