UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014715 |
|---|---|
| Receipt number | R000017104 |
| Scientific Title | Decreasing and Changing the Types and Quantities of Oral Antiepileptic: Intravenous Antiepileptic Drug as a Base Therapy. |
| Date of disclosure of the study information | 2014/08/25 |
| Last modified on | 2023/08/05 12:37:13 |
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Basic information
Public title
Decreasing and Changing the Types and Quantities of Oral Antiepileptic: Intravenous Antiepileptic Drug as a Base Therapy.
Acronym
Oral Antiepileptic adjustment with Intravenous Antiepileptic Drug.
Scientific Title
Decreasing and Changing the Types and Quantities of Oral Antiepileptic: Intravenous Antiepileptic Drug as a Base Therapy.
Scientific Title:Acronym
Oral Antiepileptic adjustment with Intravenous Antiepileptic Drug.
Region
| Japan |
Condition
Condition
Intractable epileptic patients who are taking two or more kinds of appropriate antiepileptic drugs
Classification by specialty
| Neurology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine whether we reduce the number and/or dose of oral AEDs for the intractable epileptic patients to exchange them to newer ones with IV AED as a base drug.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
After a year for drug adjustment, we estimate following; 1) the number of oral drugs patients used before and after drug adjustment, 2)the frequency of seizures before and after drug adjustment, 3) adverse events from the use of an IV AED while we withdrew several oral AEDs at one time, 4) adverse events that occurred at least for 1 year follow-up periods, and 5) the length of stay in our hospital for drug adjustment.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 1 | years-old | <= |
Age-upper limit
| 20 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The epileptic patients who are taking two or more kinds of appropriate antiepileptic drugs but have seizurse to spoil their quority of life, and whose EEG improve after the administration of an IV AED or whose clinical symptoms are not exacerbated, include this study. We did not register our work before enrolling the participants because we thought this work was not a clinical trial but a clinical treatment. So, this is the retrospective study. We acquired written informed consent about methods of trial and follow-up schedule from the patients and/or one of their parents. Therefore, we registered these contents on the Hospital Ethics Committee of Medicine and Medical care, University of Occupational and Environmental Health, JAPAN at August 1st, 2014 (Registration No. 2014-08). The Hospital Ethics Committee of Medicine and Medical care, University of Occupational and Environmental Health, JAPAN cannot admit our study as a clinical trial, but the Ethics Committee allowed us to use the data as a clinical treatment (from October 1st, 2010 to June 30th, 2013). We also register our work to the Japan Primary Registries Network.
Key exclusion criteria
The epileptic patients whose EEG did not improve after the administration of any IV AED or whose clinical symptoms were exacerbated are excluded from this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Shimono |
Organization
School of Medicine, University of Occupational and Environmental Health, Japan
Division name
Department of Pediatrics
Zip code
Address
Iseigaoka 1-1, Yahatanishi, Kitakyushu 807-8555, Japan.
TEL
093-603-1611
shimono@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Shimono |
Organization
University of Occupational and Environmental Health, Japan
Division name
Department of Pediatrics
Zip code
Address
Iseigaoka 1-1, Yahatanishi, Kitakyushu 807-8555, Japan.
TEL
093-603-1611
Homepage URL
shimono@med.uoeh-u.ac.jp
Sponsor or person
Institute
the Hospital Ethics Committee of Medicine and Medical care, University of Occupational and Environmental Health, JAPAN
Institute
Department
Personal name
Funding Source
Organization
Institution of ethics committee, University of Occupational and Environmental Health, Japan.
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
産業医科大学小児科
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Terminated
Date of protocol fixation
| 2010 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We had already finished our trial in 2019.
Management information
Registered date
| 2014 | Year | 07 | Month | 30 | Day |
Last modified on
| 2023 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017104
