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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000030797 |
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Date of registration:
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13/01/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Uncontrolled open label study of sirolimus about efficacy for epileptic seizures and safety in patients with focal cortical dysplasia type 2
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Scientific title:
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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 |
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Date of first enrolment:
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2017/12/01 |
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Target sample size:
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1 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034192 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Phase II
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Countries of recruitment
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Japan
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Contacts
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Name:
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Yukitoshi
Takahashi |
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Address:
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Shizuoka
Japan |
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Telephone:
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054-245-5446 |
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Email:
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takahashi-ped@umin.ac.jp |
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Affiliation:
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National Epilepsy Center, Shizuoka Institute of Epilepsy and Neurological Disorders, NHO Pediatrics |
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Name:
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Yukitoshi
Takahashi |
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Address:
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886 Urushiyama Aoi-ku Shizuoka 420-8688, Japan
420 8688
Japan |
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Telephone:
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054-245-5446 |
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Email:
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takahashi-ped@umin.ac.jp |
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Affiliation:
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National Epilepsy Center, Pediatrics |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 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.
Age minimum:
6years-old
Age maximum:
65years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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focal cortical dysplasia type 2
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Intervention(s)
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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)
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Primary Outcome(s)
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Reduction rate of partial seizures (including secondary GTC) among 28 days from observation period to maintenance dose period
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Secondary Outcome(s)
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Reduction rate of other seizures than partial seizures among 28 days from observation period to maintenance dose period
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Source(s) of Monetary Support
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AMED
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Ethics review
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Status: YES
Approval date: 31/10/2017
Contact:
takahashi-ped@umin.ac.jp
National Epilepsy Center,
054-245-5446
takahashi-ped@umin.ac.jp
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Results
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Results available:
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Yes |
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Date Posted:
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16/01/2023 |
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Date Completed:
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30/09/2020 |
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URL:
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in progress
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