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 137. 限局性皮質異形成 [臨床試験数:6,薬物数:4(DrugBank:2),標的遺伝子数:1,標的パスウェイ数:43] 

Searched query = "Focal cortical dysplasia"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
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1JPRN-UMIN0000335042018/10/012 April 2019An uncontrolled open-label study on the efficacy and safety of sirolimus for epileptic seizures associated with focal cortical dysplasia type-IIfocal 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 Hospital Nishi-Niigata Chuo National Hospital National Center Hospital, NCNP Shizuoka Institute of Epilepsy and Neurological Disorders Okayama University HospitalRecruiting6years-old65years-oldMale and Female15Phase 2Japan
2NCT03198949May 24, 201823 April 2019A Study Investigating the Anti-epileptic Efficacy of Afinitor (Everolimus) in Patients With Refractory Seizures Who Have Focal Cortical Dysplasia Type II (FCD II)A Prospective, Randomized, Double-blind, Placebo-controlled Cross Over Study Investigating the Anti-epileptic Efficacy of Afinitor (Everolimus) in Patients With Refractory Seizures Who Have Focal Cortical Dysplasia Type II (FCD II)Epilepsy and Focal Cortical Dysplasia IIDrug: Afinitor (everolimus)Yonsei UniversityRecruiting4 Years40 YearsAll26Phase 2Korea, Republic of
3JPRN-UMIN0000309622018/02/2810 September 2019Clinical study on efficacy and safety of sirolimus against epileptic seizures of focal cortical dysplasia type IIClinical study on efficacy and safety of sirolimus against epileptic seizures of focal cortical dysplasia type II - Study of sirolimus administration for FCDII typePatients with epilepsy with focal cortical dysplasia type 2Prescribe 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 HospitalNot Recruiting2years-old65years-oldMale and Female2Not selectedJapan
4JPRN-UMIN0000307972017/12/012 April 2019Uncontrolled open label study of sirolimus about efficacy for epileptic seizures and safety in patients with focal cortical dysplasia type 2Uncontrolled open label study of sirolimus about efficacy for epileptic seizures and safety in patients with focal cortical dysplasia type 2 - Clinical research-sirolimus FCD Shizuoka2017-1focal cortical dysplasia type 2Period: 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)
National Epilepsy Center, Shizuoka Institute of Epilepsy and Neurological Disorders, NHONot Recruiting6years-old65years-oldMale and Female1Phase 2Japan
5NCT02261753October 201416 December 2017Evaluating Dietary Intervention Before surgicaL Treatment for EpilepsyA Randomised Controlled Trial to Compare Seizure Remission Outcome Following Resective Surgery With or Without Prior Treatment With Ketogenic Diet in Children With Epilepsy the Result of Focal Cortical Dysplasia Type IICortical DysplasiaDietary Supplement: Classical ketogenic dietUniversity College, LondonUniversity of LiverpoolNot recruiting3 Years15 YearsAll3N/AUnited States;Austria;Czechia;France;Germany;Italy;Switzerland;United Kingdom;Belgium;Czech Republic
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT02451696January 201430 September 2019A Pilot Study To Evaluate The Effects of Everolimus on Brain mTOR Activity and Cortical Hyperexcitability in TSC and FCDA Pilot Study To Evaluate The Effects of Everolimus on Brain mTOR Activity and Cortical Hyperexcitability in TSC and FCDEpilepsy;Tuberous Sclerosis Complex;Focal Cortical DysplasiaDrug: EverolimusNYU Langone HealthRecruiting2 Years40 YearsAll30Phase 2United States

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