UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033606 |
|---|---|
| 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 |
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Basic information
Public title
A prospective cohort study of epileptic seizures in patients with focal cortical dysplasia type II
Acronym
A prospective cohort study of epileptic seizures in patients with focal cortical dysplasia type II(RES-FCD)
Scientific Title
A prospective cohort study of epileptic seizures in patients with focal cortical dysplasia type II
Scientific Title:Acronym
A prospective cohort study of epileptic seizures in patients with focal cortical dysplasia type II(RES-FCD)
Region
| Japan |
Condition
Condition
Epilepsy with focal cortical dysplasia type II
Classification by specialty
| Neurology | Pediatrics | Psychiatry |
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To understand the change in frequency of epileptic seizures
Basic objectives2
Others
Basic objectives -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
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Reduction rate from the baseline of the frequency of partial seizures (including secondarily generalized seizures) per 28 days after 6 months
Key secondary outcomes
-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
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 6 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(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
Key exclusion criteria
(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.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yushi |
| Middle name | |
| Last name | Inoue |
Organization
National Hospital Organization, Shizuoka Institute of Epilepsy and Neurological Disorders
Division name
Invited researcher
Zip code
420-8688
Address
Urushiyama 886, Aoi-ku, Shizuoka 420-8688, Japan
TEL
054-245-5446
contact@res-r.com
Public contact
Name of contact person
| 1st name | Yushi |
| Middle name | |
| Last name | Inoue |
Organization
National Hospital Organization, Shizuoka Institute of Epilepsy and Neurological Disorders
Division name
Invited researcher
Zip code
420-8688
Address
Urushiyama 886, Aoi-ku, Shizuoka 420-8688, Japan
TEL
054-245-5446
Homepage URL
contact@res-r.com
Sponsor or person
Institute
Research group on rare epilepsy
Institute
Department
Personal name
Funding Source
Organization
Health and Labor Sciences Research Grants
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of the NHO Shizuoka Institute of Epilepsy and Neurological Disorders
Address
Urushiyama 886, Aoi-ku, Shizuoka 420-8688, Japan
Tel
054-245-5446
307-sy02@mail.hosp.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
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）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
doi: 10.1002/acn3.51505
Publication of results
Published
Result
URL related to results and publications
doi: 10.1002/acn3.51505
Number of participants that the trial has enrolled
60
Results
The focal seizure frequency reduced by 0.5%.
Results date posted
| 2022 | Year | 08 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 12 | Month | 28 | Day |
Baseline Characteristics
Patients with epilepsy due to focal cortical dysplasia type 2 aged 6 years or older
Participant flow
Via Rare Epilepsy Syndrome Registry
Adverse events
None
Outcome measures
Comparison of seizure frequency between baseline and after 6 months
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
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.
Management information
Registered date
| 2018 | Year | 08 | Month | 02 | Day |
Last modified on
| 2022 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038125
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/08/04 | RES-FCD PRT v0.1 final.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
