UMIN-CTR Clinical Trial

Basic information
Public title	Quinidine sulfate administration for intractable epilepsy with KCNT1 gene mutation
Acronym	Quinidine sulfate administration for intractable epilepsy with KCNT1 gene mutation
Scientific Title	Quinidine sulfate administration for intractable epilepsy with KCNT1 gene mutation
Scientific Title:Acronym	Quinidine sulfate administration for intractable epilepsy with KCNT1 gene mutation
Region	Japan

Condition
Condition	Intractable epilepsy with KCNT1 gene mutation
Classification by specialty	Neurology Pediatrics
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	This study investigates the efficiency and safety of quinidine sulfate administration for intractable epilepsy patients with KCNT1 gene mutation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in frequency of epileptic seizures
Key secondary outcomes	Change in severity of epileptic seizures. Change in EEG finding. Change in psychomotor development.

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	Quinidine sulfate administration
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients of intractable epilepsy with KCNT1 gene mutation
Key exclusion criteria	The patient who is judged by the patient's physician as unsuitable for participating in this study.
Target sample size	10

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Katsumi IMAI
Organization	NHO, National Epilepsy Center, Shizuoka Institute of Epilepsy and Neurological Disorders
Division name	Department of Epileptology
Zip code
Address	886 Urushiyama, Aoi, Shizuoka-city, Shizuoka, 420-8688, HAPAN
TEL	054-245-5446
Email	imaik-1@hosp.go.jp

Public contact
1st name of contact person	1st name Middle name Last name Katsumi IMAI
Organization	NHO, National Epilepsy Center, Shizuoka Institute of Epilepsy and Neurological Disorders
Division name	Department of Epileptology
Zip code
Address	886 Urushiyama, Aoi, Shizuoka-city, Shizuoka, 420-8688, HAPAN
TEL	054-245-5446
Homepage URL
Email	imaik-1@hosp.go.jp

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

Funding Source
Organization	NHO, National Epilepsy Center, Shizuoka Institute of Epilepsy and Neurological Disorders
Organization
Division
Category of Funding Organization	Self funding
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	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	2015 Year 11 Month 02 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	Completed
Date of protocol fixation	2015 Year 07 Month 31 Day
Date of IRB	2015 Year 07 Month 31 Day
Anticipated trial start date	2015 Year 11 Month 02 Day
Last follow-up date	2019 Year 03 Month 26 Day
Date of closure to data entry	2019 Year 03 Month 26 Day
Date trial data considered complete	2019 Year 03 Month 26 Day
Date analysis concluded	2019 Year 03 Month 26 Day

Other
Other related information

Management information
Registered date	2015 Year 11 Month 02 Day
Last modified on	2019 Year 03 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022652