Unique ID issued by UMIN | UMIN000033606 |
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Receipt number | R000038125 |
Scientific Title | A prospective cohort study of epileptic seizures in patients with focal cortical dysplasia type II |
Date of disclosure of the study information | 2018/09/01 |
Last modified on | 2022/08/05 09:54:37 |
A prospective cohort study of epileptic seizures in patients with focal cortical dysplasia type II
A prospective cohort study of epileptic seizures in patients with focal cortical dysplasia type II(RES-FCD)
A prospective cohort study of epileptic seizures in patients with focal cortical dysplasia type II
A prospective cohort study of epileptic seizures in patients with focal cortical dysplasia type II(RES-FCD)
Japan |
Epilepsy with focal cortical dysplasia type II
Neurology | Pediatrics | Psychiatry |
Neurosurgery |
Others
NO
To understand the change in frequency of epileptic seizures
Others
Performed as an external control group of investigator-initiated clinical trials to assess the efficacy and safety of sirolimus in epilepsy patients with focal cortical dysplasia type II
Exploratory
Not applicable
Reduction rate from the baseline of the frequency of partial seizures (including secondarily generalized seizures) per 28 days after 6 months
-Change from the baseline of the frequency of general seizures per 28 days after 6 months
-Change from the baseline of the frequency of epileptic spasms per 28 days after 6 months
-Change from the baseline of the frequency of status epilepticus per 28 days after 6 months
-Distribution of demographics
-Status of surgical and/or medical treatment
Observational
6 | years-old | <= |
65 | years-old | >= |
Male and Female
(1) Those registered in RES-R
(2) Those with lesion diagnosed by neuroimaging or pathology as focal cortical dysplasia type II
(3) Aged 6-65 years at the time of enrollment.
(4) Those with partial seizures (objectively diagnosable simple partial seizures with motor signs, complex partial seizures, and secondarily generalized seizures) based on the International League Against Epilepsy (ILAE) international classification for epileptic seizures in 1981 (appendix 1).
(5) Having been treated for at least 52 weeks with two or more antiepileptic drugs (AEDs) after diagnosis of epilepsy.
(6) Currently on treatment with 1 to 4 AEDs.
(7) Dose and usage of AEDs, or stimulation conditions of vagus nerve stimulation (VNS) are constant for 8 weeks before the start of the baseline observation period.
(8) Having two or more partial seizures (including secondarily generalized seizures) during 28 days of the baseline observation period
(1) Those scheduled to participate in a single-group, open-label study of sirolimus against FCDII type.
(2) Those having orally ingested sirolimus or everolimus within 52 weeks before the start of the baseline observation period.
(3) In case neither the patient nor the substitute cannot accurately record the number and timing of epileptic seizures.
(4) Those with suspected progressive brain lesion in head computed tomography (CT) or magnetic resonance imaging (MRI).
(5) Those who underwent surgical treatment for epilepsy (focal resection surgery, multiple subpial transection, functional hemispherotomy, corpus callosotomy, VNS implantation, or electrodes implantation) within 28 weeks before the baseline observation period.
(6) Those with a history of suicide attempts.
(7) Those with a history or complication of substance abuse (including alcohol abuse).
(8) Those who underwent surgical operation (surgery requiring invasion into the body cavity or surgery requiring suture of three or more needles, including biopsy) within 12 weeks before baseline observation period.
(9) Those judged inappropriate as a subject of this study.
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1st name | Yushi |
Middle name | |
Last name | Inoue |
National Hospital Organization, Shizuoka Institute of Epilepsy and Neurological Disorders
Invited researcher
420-8688
Urushiyama 886, Aoi-ku, Shizuoka 420-8688, Japan
054-245-5446
contact@res-r.com
1st name | Yushi |
Middle name | |
Last name | Inoue |
National Hospital Organization, Shizuoka Institute of Epilepsy and Neurological Disorders
Invited researcher
420-8688
Urushiyama 886, Aoi-ku, Shizuoka 420-8688, Japan
054-245-5446
contact@res-r.com
Research group on rare epilepsy
Health and Labor Sciences Research Grants
Japanese Governmental office
Japan
IRB of the NHO Shizuoka Institute of Epilepsy and Neurological Disorders
Urushiyama 886, Aoi-ku, Shizuoka 420-8688, Japan
054-245-5446
307-sy02@mail.hosp.go.jp
NO
東京女子医大病院(東京都)
福岡大学病院(福岡県)
新潟大学脳研究所(新潟県)
北海道大学病院(北海道)
東北大病院(宮城県)
聖マリアンナ医科大学病院(神奈川県)
西新潟中央病院(新潟県)
国立精神・神経医療研究センター(東京都)
大阪大学病院(大阪府)
岡山大学病院(岡山県)
長崎医療センター(長崎県)
京都大学病院(京都府)
自治医科大学病院(栃木県)
愛知医大病院(愛知県)
埼玉県立小児医療センター(埼玉県)
順天堂大学病院(東京都)
久留米大学病院(福岡県)
大阪府立母子保健総合医療センター(大阪府)
NTT東日本関東病院(東京都)
東京都立神経病院(東京都)
県立延岡病院(宮崎県)
東京医科歯科大学医学部附属病院(東京都)
昭和大学病院(東京都)
医療法人社団浅ノ川 浅ノ川総合病院(石川県)
岩手医科大学附属病院(岩手県)
聖マリア病院(福岡県)
2018 | Year | 09 | Month | 01 | Day |
doi: 10.1002/acn3.51505
Published
doi: 10.1002/acn3.51505
60
The focal seizure frequency reduced by 0.5%.
2022 | Year | 08 | Month | 05 | Day |
2021 | Year | 12 | Month | 28 | Day |
Patients with epilepsy due to focal cortical dysplasia type 2 aged 6 years or older
Via Rare Epilepsy Syndrome Registry
None
Comparison of seizure frequency between baseline and after 6 months
Main results already published
2018 | Year | 07 | Month | 30 | Day |
2018 | Year | 07 | Month | 30 | Day |
2018 | Year | 09 | Month | 01 | Day |
2020 | Year | 09 | Month | 30 | Day |
We conduct a longitudinal observation study of epileptic seizures in FCD cases and make use of it as a sirolimus non-administration group for comparison and verification on the safety and efficacy of the sirolimus to the administration group.
2018 | Year | 08 | Month | 02 | Day |
2022 | Year | 08 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038125
Research Plan | |
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Registered date | File name |
2021/08/04 | RES-FCD PRT v0.1 final.pdf |
Research case data specifications | |
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Registered date | File name |
Research case data | |
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Registered date | File name |