Epileptic patients with focal cortical dysplasia type 2 Epilepsy, FCD type 2
Conditions
Interventions
sirolimus
Sponsors
Takahashi Yukitoshi
Kato Mitsuhiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse event | — |
Secondary
| Measure | Time frame |
|---|---|
| Dose & level of sirolimus around adverse event, continuation of sirolimus | — |
Contacts
Public ContactYukitoshi Takahashi
National Epilepsy Center, NHO Shizuoka Institute of Epilepsy and Neurological Disorders
Outcome results
None listed