Clinical evaluation of stiripentol in Dravet syndrome - Stiripentol in Dravet syndrome

Yushi InoueNational Epilepsy Center, Shizuoka Institute of Epilepsy and Neurological Disorders0 个研究点目标入组 10 人开始时间: 2007年11月6日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1. Clinically and electroencephalographically confirmed diagnosis of SMEI including borderline SMEI according to the classification of the International League against Epilepsy (ILAE, 1989).
•2. Aged 1 year or older (at the time of consent).
•3. Inpatients or outpatients
•4. Male or female
•5. Seizure frequency:
•- the parents/guardians of the patient are able to provide an accurate count of seizures (generalized or unilateral, tonic or clonic) together with their approximate duration.
•- having 4 or more times of seizures of any type described above during 4 weeks prior to stiripentol treatment.
•6. Currently treated with AED(s) (up to 3 AEDs, excluding rescue drugs).
•7. Are on stable AED regimens during 4 weeks prior to stiripentol treatment.
•8. A written consent from the parents/guardians of the patient.
•9. With or without gene mutations (including SCN1A), but prior testing is recommended.

•1. Liver disease or GOT/GPT of more than 3 times the upper normal limits.
•2. Kidney disease or a creatinine level of more than 1.5 mg/dL.
•3. WBC count < 2500 or platelet count < 10.0 x 10^4 /mcL, unless considered medically acceptable.
•4. History of drug hypersensitivity.
•5. Use of prohibited concomitant medications.
•6. Pregnant women.
•7. Use of another study drug or unapproved drug.
•8. For any reason is judged by the investigator to be inappropriate for study.

发起方

Yushi InoueNational Epilepsy Center, Shizuoka Institute of Epilepsy and Neurological Disorders