Clinical study on the safety of sirolimus for epileptic seizures associated with focal cortical dysplasia type II (FCDS-02)

未提供0 个研究点目标入组 23 人开始时间: 2019年12月18日最近更新: 2025年4月18日

适应症

试验速览

暂无简介。

•1.After completion of clinical trial (FCDS-01 or FCDS-03 or Hokudai FCDS or sirolimus Shizuoka 2019-1), age >= 2 years old
•2.Improvement of epileptic seizures by FCDS-01 or FCDS-03 or Hokudai FCDS or sirolimus Shizuoka 2019-1
•3.Patients whose serious adverse events causally related to sirolimus and concomitant antiepileptic drugs have not been reported in the FCDS-01, FCDS-03, Hokudai FCDS or sirolimus Shizuoka 2019-1, or whose such adverse events have resolved or become mild and sirolimus administration has been resumed or continued.
•4.Informed consent by written agreement after precise explanation

•1.Patients without accurate data of compliance, adverse event, seizure frequency, duration of seizure
•2.Possible attendance another clinical trial
•3.Prescription of PB or VGB
•4.Possible ketogenic diet therapy
•5.Pregnant patient or no agreement for contraception
•6.Basic disease inflammation, degenerative diseases
•7.Risk of suicide
•8.History of alcoholic abuse
•9.Among preceding clinical trial (FCDS-01 or FCDS-03 or Hokudai FCDS or sirolimus Shizuoka 2019-1), the following laboratory data were observed
•9-1 AST or ALT >= 2.5 folds of standard value in our hospital
•9-2 WBC < 3000 /mm3, Ht < 30%, Platelet < 80000/mm3, neutrophils < 1000/mm3
•9-3 C cr < 50ml/min, eGFR < 30mL/min/1.73m2
•9-4 HBsAg (+), HBs Ab(+) after HBV infection, HBc Ab (+)
•9-5 Uncontrolled hyperlipidemia
•10.Association of arrythmia or cardiac failure requiring treatment.
•11.Association of immunodeficiency
•12.Irregular visit to hospital
•13.Decision of inappropriate patient for this study by responsible doctor

adverse event

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发起方

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