137. 限局性皮質異形成 Focal cortical dysplasia Clinical trials / Disease details
|1||JPRN-jRCTs031190157||18/12/2019||11/12/2019||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||Epileptic patients with focal cortical dysplasia type 2 |
Epilepsy, FCD type 2
|Sirolimus 0.5-4mg (0.5-4 tablets of the study drug) is administered orally once a day in the morning.||Kato Mitsuhiro||NULL||Not Recruiting||>= 2age old||Not applicable||Both||15||Phase 2||Japan|
|2||JPRN-jRCTs041190059||09/08/2019||05/08/2019||Study about safety of sirolimus: Shizuoka 2019-1||Clinical study of sirolimus about safety for Japanese patients: Shizuoka 2019-1 - Sirolimus Shizuoka 2019-1||Epileptic patients with focal cortical dysplasia type 2 |
Epilepsy, FCD type 2
|sirolimus||Takahashi Yukitoshi||Kato Mitsuhiro||Recruiting||>= 6age old||Not applicable||Both||5||Phase 2||Japan|
|3||JPRN-UMIN000033504||2018/10/01||25/07/2018||An uncontrolled open-label study on the efficacy and safety of sirolimus for epileptic seizures associated with focal cortical dysplasia type-II||An uncontrolled open-label study on the efficacy and safety of sirolimus for epileptic seizures associated with focal cortical dysplasia type-II - An investigator-initiated clinical trial on the efficacy and safety of sirolimus for epileptic seizures associated with FCD type-II||focal cortical dysplasia (type-II)||The investigational drug (sirolimus) is orally administered once a day with the following doses:|
<Dose adjustment period>
Initial amount: 1 mg/day for body weight of less than 40 kg, and 2 mg/day for 40 kg or more.
Dose adjustment: to increase as necessary to adjust the trough concentration of sirolimus to the range of 5-15 ng/ml, and then, to shift to the maintenance therapy period.
<Maintenance therapy period>
To adopt dosage regimen and dose of sirolimus at trough concentration of 5-15 ng/ml.
|Hokkaido University HospitalNishi-Niigata Chuo National HospitalNational Center Hospital, NCNPShizuoka Institute of Epilepsy and Neurological DisordersOkayama University Hospital||NULL||Complete: follow-up complete||6years-old||65years-old||Male and Female||15||Phase 2||Japan|
|4||JPRN-UMIN000030962||2018/02/28||24/01/2018||Clinical study on efficacy and safety of sirolimus against epileptic seizures of focal cortical dysplasia type II||Clinical study on efficacy and safety of sirolimus against epileptic seizures of focal cortical dysplasia type II - Study of sirolimus administration for FCDII type||Patients with epilepsy with focal cortical dysplasia type 2||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 of Visit 2. Take it once a day in the morning.|
For test drugs (1 mg tablets), weighing less than 20 kg of sirolimus 0.5 mg / day, body weight of less than 20 kg to less than 40 kg is 1 mg / day, body weight of 40 mg or more is orally administered 2 mg / day once daily in the morning. The upper limit of the daily dose is 4 mg.
The dose was not changed in the first 4 weeks, the blood concentration of sirolimus was measured at the 4th week (visit 4), the next visit (4 weeks / visit 4-2 to 4-10) based on the examination result, From 0.5 mg / day for less than 20 kg to 1 mg / day for 20 kg or more, increase the dose and repeat the measurement of sirolimus blood concentration every 4 weeks until the trough concentration reaches 5 to 15 ng / mL, and the trough concentration. From the time when the target concentration is reached, the maintenance therapy period is entered.
As a result of the blood concentration at Visit 4, when the trough blood concentration is within the range of 5 - 15 ng / mL, it will shift to the maintenance therapy period from Visit 5 (Week 8).
Visit 5 (after week 8) is in the dose control phase and is fixed at the dose of sirolimus that has reached blood concentration of 5 - 15 ng / mL.
The maintenance therapy period will be visited 4 weeks, 8 weeks, 12 weeks after the start of maintenance therapy and will continue for 12 weeks.
The researcher who completed the procedure up to the end of the 12th week of maintenance therapy will complete the study
|Hokkaido University Hospital||NULL||Complete: follow-up continuing||2years-old||65years-old||Male and Female||2||Not selected||Japan|
|5||JPRN-UMIN000030797||2017/12/01||13/01/2018||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||focal cortical dysplasia type 2||Period: 8 weeks to 2 years|
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)
|National Epilepsy Center, Shizuoka Institute of Epilepsy and Neurological Disorders, NHO||NULL||Complete: follow-up continuing||6years-old||65years-old||Male and Female||1||Phase 2||Japan|