A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Young Adult Subjects With Dravet Syndrome (DS)

Takeda Development Center Americas, Inc.0 个研究点目标入组 142 人开始时间: 2022年11月18日最近更新: 2024年6月18日

适应症

试验速览

暂无简介。

•1. Has documented clinical diagnosis of DS.
•2. Had =12 convulsive seizures over 12 weeks before screening based on the historical information and has had =4 convulsive seizures per 28
•days during the 4- to 6-week prospective baseline period.
•3. Weighs =10 kg at the screening visit (Visit 1).
•4. Failure to control seizures despite appropriate east 1 ASM based on historical information and is currently on an antiseizure therapy or other treatment options considered as SOC.
•5. Artisanal cannabidiols are allowed at a stable dose for at least 4 weeks before the screening visit (Visit 1); the dosing regimen and manufacturer should remain constant throughout the study (Artisanal cannabidiols will not be counted as ASMs.).
•6. Currently taking 0 to 4 ASMs at stable doses for at least 4 weeks before the screening visit (Visit 1); benzodiazepines used chronically (daily) to treat seizures are considered ASMs. Fenfluramine and cannabidiol (Epidiolex) are allowed where available and should be counted as an ASM. ASM dosing regimen must remain constant throughout the study.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 100
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 42
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Unstable, clinically significant neurologic (other than the disease being studied), psychiatric, cardiovascular, ophthalmologic, pulmonary,
•hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, endocrine disease, malignancy including progressive
•tumors, or other abnormality that may impact the ability to participate in the study or that may potentially confound the study results. It is the
•responsibility of the investigator to assess the clinical significance; however, consultation with the medical monitor may be warranted.

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