Research of sirolimus administration for FCD II type

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031190157

Enrollment

Registered

2019-12-11

Start date

2019-12-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epileptic patients with focal cortical dysplasia type 2 Epilepsy, FCD type 2

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

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 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

Design outcomes

Primary

Measure	Time frame
adverse event	—

Secondary

Measure	Time frame
Dose & level of sirolimus around adverse event, continuation of sirolimus, seizure frequency	—

Contacts

Public ContactMitsuhiro Kato

SHOWA Medical University School of Medicine

ktmthr@gmail.com+81-3-3784-8565

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026