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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030797
Receipt No. 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 2018/07/16

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Basic information
Public title Uncontrolled open label study of sirolimus about efficacy for epileptic seizures and safety in patients with focal cortical dysplasia type 2
Acronym Clinical research-sirolimus FCD Shizuoka2017-1
Scientific Title Uncontrolled open label study of sirolimus about efficacy for epileptic seizures and safety in patients with focal cortical dysplasia type 2
Scientific Title:Acronym Clinical research-sirolimus FCD Shizuoka2017-1
Region
Japan

Condition
Condition focal cortical dysplasia type 2
Classification by specialty
Neurology Pediatrics Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To reveal the efficacy of sirolimus for epileptic seizures, safety and pharmacokinetics in patients with focal cortical dysplasia type 2
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Reduction rate of partial seizures (including secondary GTC) among 28 days from observation period to maintenance dose period
Key secondary outcomes Reduction rate of other seizures than partial seizures among 28 days from observation period to maintenance dose period

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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)
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. 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.
Key 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.
Target sample size 1

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukitoshi Takahashi
Organization National Epilepsy Center,
Shizuoka Institute of Epilepsy and Neurological Disorders, NHO
Division name Pediatrics
Zip code
Address 886 Urushiyama Aoi-ku Shizuoka 420-8688, Japan
TEL 054-245-5446
Email takahashi-ped@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukitoshi Takahashi
Organization National Epilepsy Center,
Division name Pediatrics
Zip code
Address 886 Urushiyama Aoi-ku Shizuoka 420-8688, Japan
TEL 054-245-5446
Homepage URL
Email takahashi-ped@umin.ac.jp

Sponsor
Institute National Epilepsy Center,
Shizuoka Institute of Epilepsy and Neurological Disorders, NHO
Institute
Department

Funding Source
Organization AMED
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
Address
Tel
Email

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 国立病院機構静岡てんかん・神経医療センター

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 13 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 No longer recruiting
Date of protocol fixation
2017 Year 10 Month 31 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 01 Day
Last follow-up date
2020 Year 09 Month 30 Day
Date of closure to data entry
2020 Year 10 Month 31 Day
Date trial data considered complete
2020 Year 10 Month 31 Day
Date analysis concluded
2020 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 01 Month 13 Day
Last modified on
2018 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034192

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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