An open-label study to investigate the safety and efficacy of cannabidiol oral solution (GWP42003-P) in Japanese children and adults as adjunctive treatment for seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex

Yamamoto Tomoyuki0 个研究点目标入组 84 人开始时间: 2022年4月25日最近更新: 2024年5月27日

适应症

试验速览

暂无简介。

•1.Participant must be Japanese.
•2.Participan must fulfill conditions-specific criteria for Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC).
•3.Male or female >= 1 to <= 65 years of age at time of signing the informed consent form.
•4.Taking 1 or more antiepileptic drugs (AEDs) at a stable dose for at least 4 weeks prior to screening.
•5.Complete at least 25 days of seizure diary entries during the 28 days of the baseline period.

•1. Etiology of seizures is a progressive neurologic disease. Participants with TSC will not be excluded from study participation unless there is a progressive tumor.
•2. Has had an anoxic episode requiring resuscitation within 6 months of screening.
•3. Has clinically significant medical conditions other than epilepsy.
•4. Has undergone surgery for epilepsy in the 26 weeks prior to screening.
•5. Has clinically significant abnormal laboratory values, in the investigator's opinion, at screening or enrollment.
•6. Has a history of pseudo-seizures.
•7. Has clinically significant unstable medical conditions other than epilepsy.
•8. Any history of suicidal behaviour or any suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS)/Children's C-SSRS in the last month, or at screening. This criterion applies only to participants >= 4 years of age.
•9. Known or suspected hypersensitivity to cannabinoids, or any of the excipients of study intervention, such as sesame oil.
•10. In the opinion of the investigator, the participant has clinically significant abnormalities in the 12-lead electrocardiogram (ECG) measured at screening or enrollment, or any concurrent cardiovascular conditions, which will interfere with the ability to read their ECGs.

发起方

Yamamoto Tomoyuki