Unique ID issued by UMIN | UMIN000030797 |
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Receipt number | R000034192 |
Scientific Title | Uncontrolled open label study of sirolimus about efficacy for epileptic seizures and safety in patients with focal cortical dysplasia type 2 |
Date of disclosure of the study information | 2018/01/13 |
Last modified on | 2023/01/16 14:43:08 |
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
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
Japan |
focal cortical dysplasia type 2
Neurology | Pediatrics | Neurosurgery |
Others
NO
To reveal the efficacy of sirolimus for epileptic seizures, safety and pharmacokinetics in patients with focal cortical dysplasia type 2
Pharmacokinetics
Exploratory
Phase II
Reduction rate of partial seizures (including secondary GTC) among 28 days from observation period to maintenance dose period
Reduction rate of other seizures than partial seizures among 28 days from observation period to maintenance dose period
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
1
Treatment
Medicine |
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)
6 | years-old | <= |
65 | years-old | >= |
Male and Female
1. Diagnossi of FCD type 2 by MRI and /or histological exaamination.
2. Age (6 years to 65 years old), body weitht more than 20 Kg.
3. partial seizures difined by classification of ILAE.
4. Seizure continued, in spite of treatment for one year, by more than 2 AEDS.
5. Current AEDs:1-4 AEDs
6. No change of prescription of AEDs from obserbational stage.
7. Written informed consent from gurdians or patients.
8. Seizure frequency: more than two times among obserbational stage.
1. Other clinical trials in less than one month before obsebational stage.
2. Experience of eberolimus or sirolimus treatment.
3. Imposible counting of seizure frequency and duration.
4. Possible inflammation and /or degeneration suggested by CT , MRI, etc.
5. No epilepsy surgery among 6 months before obserbational stage. Partients with VNS before 6 months of obserbational stge, stimulation frequency is consistent.
6. Treatment with PB or VGB in 6 months before obserbational stage.
7. Current ketogenic diet.
8. History of suicide.
9. History or comorbidity of addiction including alcohol.
10. Pregnant mowen and breast-feedin women.
11. active hepatitis.
12. arhythmia with treatment.
13. heart failure with treatment.
14. immunodeficiency
15. surgical intervention in 8 weeks before obserbational stage.
16. Judgement of contraindication by reserchers.
1
1st name | Yukitoshi |
Middle name | |
Last name | Takahashi |
National Epilepsy Center,
Shizuoka Institute of Epilepsy and Neurological Disorders, NHO
Pediatrics
420 8688
Shizuoka
054-245-5446
takahashi-ped@umin.ac.jp
1st name | Yukitoshi |
Middle name | |
Last name | Takahashi |
National Epilepsy Center,
Pediatrics
420 8688
886 Urushiyama Aoi-ku Shizuoka 420-8688, Japan
054-245-5446
takahashi-ped@umin.ac.jp
National Epilepsy Center,
Shizuoka Institute of Epilepsy and Neurological Disorders, NHO
AMED
Japanese Governmental office
Japan
National Epilepsy Center,
886 Urushiyama Aoi-ku Shizuoka 420-8688, Japan
054-245-5446
takahashi-ped@umin.ac.jp
NO
国立病院機構静岡てんかん・神経医療センター
2018 | Year | 01 | Month | 13 | Day |
in progress
Unpublished
in progress
1
Effectiveness for seizure outcome was not confirmed.
2023 | Year | 01 | Month | 16 | Day |
adolescent female
one patient
nothing
seizure outcome
Completed
2017 | Year | 10 | Month | 31 | Day |
2017 | Year | 10 | Month | 31 | Day |
2017 | Year | 12 | Month | 01 | Day |
2020 | Year | 09 | Month | 30 | Day |
2020 | Year | 10 | Month | 31 | Day |
2020 | Year | 10 | Month | 31 | Day |
2020 | Year | 10 | Month | 31 | Day |
2018 | Year | 01 | Month | 13 | Day |
2023 | Year | 01 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034192
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