Study about safety of sirolimus: Shizuoka 2019-1

JRCT ID: jRCTs041190059

Registered date:05/08/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Epileptic patients with focal cortical dysplasia type 2
• Date of first enrollment: 09/08/2019
• Target sample size: 5
• Study type: Interventional
• Intervention(s): sirolimus

Outcome(s)

• Primary Outcome: adverse event
• Secondary Outcome: Dose & level of sirolimus around adverse event, continuation of sirolimus

Key inclusion & exclusion criteria

• Age minimum: >= 6age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.After completion of clinical trial (FCDS-01) in Shizuoka MINDs, Age, 6-65 years old; bodyweight >= 20Kg
2.Improvement of epileptic seizures by FCDS-01
3.No severe adverse effect by sirolimus or antiepileptic drugs in preceding clinical trial (FCDS-01)
4.Informed consent by written agreement after precise explanation

Exclude criteria

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), 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

Related Information

• Primary Sponsor: Takahashi Yukitoshi
• Secondary Sponsor: Kato Mitsuhiro
• Source(s) of Monetary Support: AMED under Grant Number JP18lk0201069s0502