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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033606
Receipt No. 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 2019/08/03

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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 Director of Hospital
Zip code 420-8688
Address Urushiyama 886, Aoi-ku, Shizuoka 420-8688, Japan
TEL 054-245-5446
Email 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 Director of Hospital
Zip code 420-8688
Address Urushiyama 886, Aoi-ku, Shizuoka 420-8688, Japan
TEL 054-245-5446
Homepage URL
Email contact@res-r.com

Sponsor
Institute Research group on rare epilepsy
Institute
Department

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
Email contact@res-r.com

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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 07 Month 30 Day
Date of IRB
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
2019 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038125

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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