UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034986 |
|---|---|
| Receipt number | 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 | 2020/05/26 09:59:26 |
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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 | Yuto |
| Middle name | |
| Last name | Uchida |
Organization
Nagoya City University
Toyokawa City Hospital
Division name
Neurology
Zip code
467-8601
Address
Kawasumi Mizuho-ku Nagoya
TEL
0528538094
uchidayuto0720@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yuto |
| Middle name | |
| Last name | Uchida |
Organization
Nagoya City University
Division name
Neurology
Zip code
4670-8601
Address
1 Kawasumi Mizuho-ku, Nagoya
TEL
0528538094
Homepage URL
uchidayuto0720@yahoo.co.jp
Sponsor or person
Institute
Department of Neurology, Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
Nagoya City University
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
Nagoya City University
Address
1 Kawasumi, Mizuho-ku, Nagoya
Tel
0528538094
shinkei@med.nagoya-cu.ac.jp
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
| 2020 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039899
| Research Plan | |
|---|---|
| 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 |
