137. Focal cortical dysplasia
8 clinical trials,   4 drugs   (DrugBank: 2 drugs),   1 drug target gene,   50 drug target pathways

Searched query = "Focal cortical dysplasia", "FCD"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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Status
Inclusion_
agemin
Inclusion_
agemax
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gender
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size
PhaseCountries
1JPRN-jRCTs031190157
18/12/201911/12/2019Research of sirolimus administration for FCD II typeClinical 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 MitsuhiroNULLRecruiting>= 2age oldNot applicableBoth15Phase 2Japan
2JPRN-jRCTs041190059
09/08/201905/08/2019Study about safety of sirolimus: Shizuoka 2019-1Clinical 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
sirolimusTakahashi YukitoshiKato MitsuhiroRecruiting>= 6age oldNot applicableBoth5Phase 2Japan
3JPRN-UMIN000033504
2018/10/0125/07/2018An uncontrolled open-label study on the efficacy and safety of sirolimus for epileptic seizures associated with focal cortical dysplasia type-IIAn 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 HospitalNULLComplete: follow-up continuing6years-old65years-oldMale and Female15Phase 2Japan
4NCT03198949
(ClinicalTrials.gov)
May 24, 201813/6/2017A 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 UniversityNULLRecruiting4 Years40 YearsAll26Phase 2Korea, Republic of
5JPRN-UMIN000030962
2018/02/2824/01/2018Clinical 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 type Patients 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 HospitalNULLComplete: follow-up continuing2years-old65years-oldMale and Female2Not selectedJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6JPRN-UMIN000030797
2017/12/0113/01/2018Uncontrolled 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 Shizuoka2017-1 focal 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, NHONULLComplete: follow-up continuing6years-old65years-oldMale and Female1Phase 2Japan
7NCT02261753
(ClinicalTrials.gov)
October 201426/9/2014Evaluating 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 LiverpoolTerminated3 Years15 YearsAll3N/AUnited States;Austria;Czechia;France;Germany;Italy;Switzerland;United Kingdom;Belgium;Czech Republic
8NCT02451696
(ClinicalTrials.gov)
January 20148/10/2014A 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 HealthNULLCompleted2 Years40 YearsAll15Phase 2United States