Epilepsy with focal cortical dysplasia type II
Conditions
Interventions
None listed
Sponsors
Research group on rare epilepsy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Those registered in RES-R (2) Those with lesion diagnosed by neuroimaging or pathology as focal cortical dysplasia type II (3) Aged 6-65 years at the time of enrollment. (4) Those with partial seizures (objectively diagnosable simple partial seizures with motor signs, complex partial seizures, and secondarily generalized seizures) based on the International League Against Epilepsy (ILAE) international classification for epileptic seizures in 1981 (appendix 1). (5) Having been treated for at least 52 weeks with two or more antiepileptic drugs (AEDs) after diagnosis of epilepsy. (6) Currently on treatment with 1 to 4 AEDs. (7) Dose and usage of AEDs, or stimulation conditions of vagus nerve stimulation (VNS) are constant for 8 weeks before the start of the baseline observation period. (8) Having two or more partial seizures (including secondarily generalized seizures) during 28 days of the baseline observation period
Exclusion criteria
Exclusion criteria: (1) Those scheduled to participate in a single-group, open-label study of sirolimus against FCDII type. (2) Those having orally ingested sirolimus or everolimus within 52 weeks before the start of the baseline observation period. (3) In case neither the patient nor the substitute cannot accurately record the number and timing of epileptic seizures. (4) Those with suspected progressive brain lesion in head computed tomography (CT) or magnetic resonance imaging (MRI). (5) Those who underwent surgical treatment for epilepsy (focal resection surgery, multiple subpial transection, functional hemispherotomy, corpus callosotomy, VNS implantation, or electrodes implantation) within 28 weeks before the baseline observation period. (6) Those with a history of suicide attempts. (7) Those with a history or complication of substance abuse (including alcohol abuse). (8) Those who underwent surgical operation (surgery requiring invasion into the body cavity or surgery requiring suture of three or more needles, including biopsy) within 12 weeks before baseline observation period. (9) Those judged inappropriate as a subject of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction rate from the baseline of the frequency of partial seizures (including secondarily generalized seizures) per 28 days after 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| -Change from the baseline of the frequency of general seizures per 28 days after 6 months -Change from the baseline of the frequency of epileptic spasms per 28 days after 6 months -Change from the baseline of the frequency of status epilepticus per 28 days after 6 months -Distribution of demographics -Status of surgical and/or medical treatment | — |
Countries
Japan
Contacts
Public ContactYushi Inoue
National Hospital Organization, Shizuoka Institute of Epilepsy and Neurological Disorders Invited researcher
Outcome results
None listed