UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023741 |
|---|---|
| Receipt number | R000027344 |
| Scientific Title | Stiripentol (diacomit(R)) for refractory epilepsy patients with autoimmune encephalitis |
| Date of disclosure of the study information | 2016/08/25 |
| Last modified on | 2016/08/23 23:33:40 |
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Basic information
Public title
Stiripentol (diacomit(R)) for refractory epilepsy patients with autoimmune encephalitis
Acronym
Stiripentol (diacomit(R)) for refractory epilepsy patients with autoimmune encephalitis
Scientific Title
Stiripentol (diacomit(R)) for refractory epilepsy patients with autoimmune encephalitis
Scientific Title:Acronym
Stiripentol (diacomit(R)) for refractory epilepsy patients with autoimmune encephalitis
Region
| Japan |
Condition
Condition
refractory epilepsy
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Control of seizures in refractory epilepsy with autoimmune encephalitis is mostly difficult, even with multiple antiepileptic drugs(AEDs), or for restriction of AEDs on account of drug allergy. If no more choice of AEDs, to control seizures, stiripentol which is reported useful in some cases of refractory epilepsy will be administered.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
neurological sign: continuous observation about presence or absence, frequency, and duration of seizures after medication
Key secondary outcomes
electroencephalogram(EEG): continuous observation about presence or absence of epileptic discharges in simple EEG fitted all the time, and 10-20 EEG at every two weeks after medication
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
stiripentol
1000mg per day, oral twice-daily dosage at first medication
dose up 500mg per day every week
if no adverse effect, dose up until seizure is free, or up to 2500mg maximum dose per day
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
autoimmune encephalitis is diagnosed in adult cases
uncontrolled seizures are prolonged even treated with useful multiple antiepileptic drugs(AEDs), or no other AEDs can be medicated on account of drug allergy.
Key exclusion criteria
patients allergic to component of this drug
pregnant or possibly pregnant women
patients chief or sub investigator diagnose inappropriate
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Okita |
Organization
Nagoya City University
Division name
Department of Neurology
Zip code
Address
Aza Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya-city, Aichi
TEL
052-853-8094
neuron4356@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Okita |
Organization
Nagoya City University
Division name
Department of Neurology
Zip code
Address
Aza Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya-city, Aichi
TEL
052-853-8094
Homepage URL
neuron4356@yahoo.co.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
Nagoya City University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 08 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 23 | Day |
Last modified on
| 2016 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027344
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
