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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023741
Receipt No. 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

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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
Email 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
Email neuron4356@yahoo.co.jp

Sponsor
Institute Nagoya City University
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027344

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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