137. Focal cortical dysplasia
[
6 clinical trials,
4 drugs（DrugBank:
2 drugs),
1 target gene / 43 target pathways ]
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.
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-UMIN000033504 | 2018/10/01 | 2 April 2019 | An uncontrolled open-label study on the efficacy and safety of sirolimus for epileptic seizures associated with focal cortical dysplasia 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 Hospital Nishi-Niigata Chuo National Hospital National Center Hospital, NCNP Shizuoka Institute of Epilepsy and Neurological Disorders Okayama University Hospital | Recruiting | 6years-old | 65years-old | Male and Female | 15 | Phase 2 | Japan | ||
| 2 | NCT03198949 | May 24, 2018 | 23 April 2019 | A 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 II | Drug: Afinitor (everolimus) | Yonsei University | Recruiting | 4 Years | 40 Years | All | 26 | Phase 2 | Korea, Republic of | |
| 3 | JPRN-UMIN000030962 | 2018/02/28 | 10 September 2019 | 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 | Not Recruiting | 2years-old | 65years-old | Male and Female | 2 | Not selected | Japan | |
| 4 | JPRN-UMIN000030797 | 2017/12/01 | 2 April 2019 | 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 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, NHO | Not Recruiting | 6years-old | 65years-old | Male and Female | 1 | Phase 2 | Japan | |
| 5 | NCT02261753 | October 2014 | 16 December 2017 | Evaluating Dietary Intervention Before surgicaL Treatment for Epilepsy | A 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 II | Cortical Dysplasia | Dietary Supplement: Classical ketogenic diet | University College, London | University of Liverpool | Not recruiting | 3 Years | 15 Years | All | 3 | N/A | United States;Austria;Czechia;France;Germany;Italy;Switzerland;United Kingdom;Belgium;Czech Republic |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT02451696 | January 2014 | 30 September 2019 | A Pilot Study To Evaluate The Effects of Everolimus on Brain mTOR Activity and Cortical Hyperexcitability in TSC and FCD | A Pilot Study To Evaluate The Effects of Everolimus on Brain mTOR Activity and Cortical Hyperexcitability in TSC and FCD | Epilepsy;Tuberous Sclerosis Complex;Focal Cortical Dysplasia | Drug: Everolimus | NYU Langone Health | Recruiting | 2 Years | 40 Years | All | 30 | Phase 2 | United States |