Patients with epilepsy with focal cortical dysplasia type 2
Conditions
Interventions
Prescribe the study medicine at the start of the gradual increase period (Visit 20 weeks) after the end of the preview phase. Administration of the study drug starts from the morning the following day
Sponsors
Hokkaido University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Persons who are diagnosed pathologically by having localized cortical dysplasia type2 Patient who is treated for at least 1 year with two or more antiepileptic drugs after diagnosis with epilepsy. Patients under treatment with 1 to 4 antiepileptic drugs. Patients whose dose and usage of antiepileptic drug administration are constant from 28 days prior to the start of the preview period prior to obtaining consent. Patients with two or more epileptic seizures in 28 days during the previewing period.
Exclusion criteria
Exclusion criteria: 1) Patients taking oral administration of other test drugs (drugs used in other clinical studies / clinical trials) before the start of the study, just before the observation period. 2) Currently, patients taking sirolimus or everolimus internally or who have ever taken internal medicine. 3) Felbamate, Vigabatrin was taking within 6 months. 4) Patients who can not accurately record the number and time of epileptic seizures by the patient or substitute. 5) Patients who are suspected of progressive lesions with Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) performed so far. 6) Patients who underwent cerebral surgery for epilepsy (cortical resection, functional hemisphere dissection, cerebral ablation, vagus nerve stimulation) within 180 days prior to obtaining consent. 7) Patients during ketogenic diet therapy. 8) Patients who have suicide attempts in the past. 9) Patients with a history or complication of substance abuse (including alcohol abuse). 10) Patients who are pregnant women who can not perform contraception during the study period (including partners), pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety in clinical research enforcement and presence or absence of occurrence of adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage reduction in the incidence of epileptic seizures per week during fixed administration period, variable administration period (dose control period) of sirolimus, compared with the previous observation period without administration | — |
Countries
Japan
Contacts
Public ContactHideaki Shiraishi
Hokkaido University Hospital Department of Pediatrics
Outcome results
None listed