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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034986
Receipt No. R000039899
Scientific Title Stiripentol for the treatment of pharmacoresistant epilepsy with drug eruptions
Date of disclosure of the study information 2018/11/25
Last modified on 2019/05/26

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Basic information
Public title Stiripentol for the treatment of pharmacoresistant epilepsy with drug eruptions
Acronym STP for pharmacoresistant epilepsy with drug eruptions
Scientific Title Stiripentol for the treatment of pharmacoresistant epilepsy with drug eruptions
Scientific Title:Acronym STP for pharmacoresistant epilepsy with drug eruptions
Region
Japan

Condition
Condition Patients with pharmacoresistant epilepsy with drug eruptions
Classification by specialty
Medicine in general Neurology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the efficacy of Stiripentol for both epileptic seizure and drug eruption in patients with pharmacoresistant epilepsy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes The efficacy of Stiripentol for both epileptic seizure and drug eruption
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Stiripentol: the initial dose was low (500 mg/d) and was then increased stepwise (500 mg/wk) until reaching a maintenance dose
Interventions/Control_2 Anti-epileptic drugs other than Stiripentol
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
16 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Patients with pharmacoresistant epilepsy with drug eruptions
Patients were included in the study after giving informed consent.
Key exclusion criteria Others than those above
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuto Uchida
Organization Nagoya City University
Toyokawa City Hospital
Division name Neurology
Zip code
Address Kawasumi Mizuho-ku Nagoya
TEL 0528538094
Email uchidayuto0720@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuto Uchida
Organization Nagoya City University
Division name Neurology
Zip code
Address 1 Kawasumi Mizuho-ku, Nagoya
TEL 0528538094
Homepage URL
Email uchidayuto0720@yahoo.co.jp

Sponsor
Institute Department of Neurology, Nagoya City University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Department of Neurology, Nagoya City University, Graduate School of Medical Sciences

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 名古屋市立大学

Other administrative information
Date of disclosure of the study information
2018 Year 11 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 Open public recruiting
Date of protocol fixation
2018 Year 11 Month 24 Day
Date of IRB
2019 Year 01 Month 15 Day
Anticipated trial start date
2018 Year 11 Month 24 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
2025 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 24 Day
Last modified on
2019 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039899

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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