Uncontrolled open label study of sirolimus about efficacy for epileptic seizures and safety in patients with focal cortical dysplasia type 2

Uncontrolled open label study of sirolimus about efficacy for epileptic seizures and safety in patients with focal cortical dysplasia type 2 - Clinical research-sirolimus FCD Shizuoka2017-1

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000030797

Enrollment

Registered

2018-01-13

Start date

2017-12-01

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

focal cortical dysplasia type 2

Interventions

Period: 8 weeks to 2 years Initial dose: 1mg/day for boy weight from 20 to 40Kg 2mg/day for body weight above 40Kg Increasing dose: 1mg/day until the level of 5-15ng/ml (sirolimus)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnossi of FCD type 2 by MRI and /or histological exaamination. 2. Age (6 years to 65 years old), body weitht more than 20 Kg. 3. partial seizures difined by classification of ILAE. 4. Seizure continued, in spite of treatment for one year, by more than 2 AEDS. 5. Current AEDs:1-4 AEDs 6. No change of prescription of AEDs from obserbational stage. 7. Written informed consent from gurdians or patients. 8. Seizure frequency: more than two times among obserbational stage.

Exclusion criteria

Exclusion criteria: 1. Other clinical trials in less than one month before obsebational stage. 2. Experience of eberolimus or sirolimus treatment. 3. Imposible counting of seizure frequency and duration. 4. Possible inflammation and /or degeneration suggested by CT , MRI, etc. 5. No epilepsy surgery among 6 months before obserbational stage. Partients with VNS before 6 months of obserbational stge, stimulation frequency is consistent. 6. Treatment with PB or VGB in 6 months before obserbational stage. 7. Current ketogenic diet. 8. History of suicide. 9. History or comorbidity of addiction including alcohol. 10. Pregnant mowen and breast-feedin women. 11. active hepatitis. 12. arhythmia with treatment. 13. heart failure with treatment. 14. immunodeficiency 15. surgical intervention in 8 weeks before obserbational stage. 16. Judgement of contraindication by reserchers.

Design outcomes

Primary

Measure	Time frame
Reduction rate of partial seizures (including secondary GTC) among 28 days from observation period to maintenance dose period	—

Secondary

Measure	Time frame
Reduction rate of other seizures than partial seizures among 28 days from observation period to maintenance dose period	—

Countries

Japan

Contacts

Public ContactYukitoshi Takahashi

National Epilepsy Center, Pediatrics

takahashi-ped@umin.ac.jp054-245-5446

Outcome results

None listed

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