UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044614 |
|---|---|
| Receipt number | R000050841 |
| Scientific Title | Correlation between effectiveness and blood concentration of lacosamide internal use for focal epilepsy |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2024/12/26 20:31:40 |
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Basic information
Public title
Correlation between effectiveness and blood concentration of lacosamide internal use for focal epilepsy
Acronym
Study on effectiveness of lacamamide internal use
Scientific Title
Correlation between effectiveness and blood concentration of lacosamide internal use for focal epilepsy
Scientific Title:Acronym
Correlation between efficacy and blood concentration of Lacosamine
Region
| Japan |
Condition
Condition
epilepsy
Classification by specialty
| Neurology | Pediatrics | Psychiatry |
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The correlation between effectiveness of lacosamide and its peak blood level is recognized.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
seizure frequency reduction rate
peak blood level of lacosamide
correlation coefficient
These results are verified by Spearman's rank correlation coefficient to determine the correlation.
Key secondary outcomes
seizure frequency reduction rate
peak blood level of lacosamide
p-value
When the correlation is low in the primary outcome, the effective group (seizure frequency reduction rate of 50% or more) and the ineffective group (less than 50%) are compared, and a significant difference in blood concentration is confirmed.
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 | days-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
children with focal epilepsy onset in childhood
children who developed from birth to under 16 years of age
children with good adherence
Children who can accurately report the details and frequency of epileptic seizures, or children who have own guardian who can report them.
Key exclusion criteria
children who cannot measure blood levels
when the patient or their guardian refuses to take lacosamide
children who have difficulty continuing treatment due to the side effects of lacosamide
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Iwasaki |
Organization
Kawasaki Municipal Tama Hospital
Division name
pediatrics
Zip code
214-8525
Address
30-37 Shukugawara, Kawasaki City, Kanagawa Prefecture, Japan
TEL
0449338111
tiwasaki52@gmail.com
Public contact
Name of contact person
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Iwasaki |
Organization
Kawasaki Municipal Tama Hospital
Division name
pediatrics
Zip code
214-8525
Address
30-37 Shukugawara, Kawasaki City, Kanagawa Prefecture, Japan
TEL
0449338111
Homepage URL
tiwasaki52@gmail.com
Sponsor or person
Institute
Toshiyuki Iwasaki
pediatrics,Kawasaki Municipal Tama Hospital
Institute
Department
Personal name
Toshiyuki Iwasaki
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Municipal Tama Hospital
Address
30-37 Shukugawara, Kawasaki City, Kanagawa Prefecture, Japan
Tel
0449338111
tiwasaki52@gmail.com
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
| 2021 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
101
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
| 2020 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
analytical observational study
retrospective cohort study
Management information
Registered date
| 2021 | Year | 06 | Month | 22 | Day |
Last modified on
| 2024 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050841
