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

Research of sirolimus administration for FCD II type (FCDS-02)

Kato Mitsuhiro

SHOWA Medical University School of Medicine

1-5-8 Hatanodai, Shinagawa-ku, Tokyo

ktmthr@gmail.com

Kato Mitsuhiro

SHOWA Medical University School of Medicine

1-5-8 Hatanodai, Shinagawa-ku, Tokyo

+81-3-3784-8565

ktmthr@gmail.com

Suspended

Dec. 11, 2019

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

Both

Epileptic patients with focal cortical dysplasia type 2

Sirolimus (tablets or granules) is administered orally once a day in the morning.

Epilepsy, FCD type 2

adverse event

Dose & level of sirolimus around adverse event, continuation of sirolimus, seizure frequency

+81-3-3784-8129

Nov. 18, 2019

none