UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028397 |
|---|---|
| Receipt number | R000032513 |
| Scientific Title | Pharmacokinetics and effectiveness of intravenous Levetiracetam administration for patients with status epilepticus |
| Date of disclosure of the study information | 2017/07/27 |
| Last modified on | 2021/08/01 12:23:28 |
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Basic information
Public title
Pharmacokinetics and effectiveness of intravenous Levetiracetam administration for patients with status epilepticus
Acronym
Pharmacokinetics of Levetiracetam
Scientific Title
Pharmacokinetics and effectiveness of intravenous Levetiracetam administration for patients with status epilepticus
Scientific Title:Acronym
Pharmacokinetics of Levetiracetam
Region
| Japan |
Condition
Condition
Status epilepticus
Classification by specialty
| Neurology | Neurosurgery | Emergency medicine |
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the pharmacokinetics and safety of Levetiracetam (2500mg) by intravenous administration for patients with convulsive status epileptics
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Maximum blood concentration just after the initial Levetiracetam administration and the minimum blood level at 12 and 48 hours later
Key secondary outcomes
Seizure suppression during Levetiracetam administration.
Electroencephalogram within 24 hours after initial Levetiracetam administration, Biochemistry.
Vital signs.
Side effects.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who was eligible to another anticonvulsant drug even after benzodiazepine administration
Key exclusion criteria
Patients with contraindication to Levetiracetam administration.
Patients with decreased renal function(under CCr:30ml/min).
Patients who required haemodialysis or renal replacement therapy.
Patients who had taken levetiracetam tablets previously on administration.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kaneko |
| Middle name | |
| Last name | Junya |
Organization
Nippon Medical School Tama Nagayama Hospital
Division name
Emergency and critical care center
Zip code
206-8512
Address
1-7-1 Nagayama, Tama-shi,Tokyo-to,Japan
TEL
042-371-2111
kanekojunya0125@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kaneko |
| Middle name | |
| Last name | Junya |
Organization
Nippon Medical School Tama Nagayama Hospital
Division name
Emergency and critical care center
Zip code
206-8512
Address
1-7-1 Nagayama, Tama-shi,Tokyo-to,Japan
TEL
042-371-2111
Homepage URL
https://www.nms.ac.jp/tama-h/section/er.html
kanekojunya0125@yahoo.co.jp
Sponsor or person
Institute
Nippon Medical School Tama Nagayama Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Nippon Medical School Tama Nagayama Hospital
Address
1-7-1 Nagayama, Tama-shi,Tokyo-to,Japan
Tel
042-371-2111
k-harada@nms.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
日本医科大学多摩永山病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 27 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/33984709/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/33984709/
Number of participants that the trial has enrolled
20
Results
Median blood LEV (2500 mg) concentration at 15 min after administration was 81.6 microgramg/mL. The median trough concentration after 12, 48, and 96 h was 28.8, 10.5, and 9.1 microgram/mL, respectively. Moreover, 95% of patients had trough concentration above the lower limit of the therapeutic blood concentration (over 12 microgram/mL) after 12 h.
Results date posted
| 2021 | Year | 08 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The inclusion criteria were patients diagnosed with SE and aged 20 years or older. The exclusion criteria were patients receiving LEV daily and those with a low renal function (creatinine clearance < 30 mL/min),which might affect blood LEV concentration.
Participant flow
In this observational clinical study, 20 patients who visited the Department of Emergency and Critical Care Medicine, Nippon Medical School, Tama-Nagayama Hospital, a tertiary care emergency medical and trauma center in the western part of Tokyo, Japan, were enrolled from July 2017 to July 2019.
Adverse events
No abnormal findings were noted in blood tests and vital sign examination, although the AST/ALT levels increased in 10% of the patients.
Outcome measures
The primary outcomes were blood LEV concentration and the proportion of patients with trough LEV concentration within the therapeutic range 15 min after administration (peak value) and 12, 48, and 96h after the first administration (trough value). The secondary outcomes were the discontinuation of apparent convulsive seizure evaluated at 15 min and 12, 48, and 96 h; epileptic wave on electroencephalogram(EEG) within 24 h; tracheal intubation proportion; adverse events related to blood parameters (blood cell count, creatinine level, and transaminase level) defined according to the Common Terminology Criteria for Adverse Events version 5.0 [7]; and abnormal vital signs (hypotension, bradycardia, tachycardia, hypoxia, or tracheal stenosis) after bolus LEV administration.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 07 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2017 | Year | 07 | Month | 27 | Day |
Last modified on
| 2021 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032513
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