UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Stiripentol (diacomit(R)) for refractory epilepsy patients with autoimmune encephalitis
Title of the study (Brief title)	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	Kenji Okita
Organization	Nagoya City University
Division name	Department of Neurology
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	Kenji Okita
Organization	Nagoya City University
Division name	Department of Neurology
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 08 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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