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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028397
Receipt No. 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 2017/07/27

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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
Middle name
Last name Junya Kaneko
Organization Nippon Medical School Tama Nagayama Hospital
Division name Emergency and critical care center
Zip code
Address 1-7-1 Nagayama, Tama-shi,Tokyo-to,Japan
TEL 042-371-2111
Email kanekojunya0125@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junya Kaneko
Organization Nippon Medical School Tama Nagayama Hospital
Division name Emergency and critical care center
Zip code
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
Email kanekojunya0125@yahoo.co.jp

Sponsor
Institute Nippon Medical School Tama Nagayama Hospital
Institute
Department

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
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 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
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
2017 Year 07 Month 01 Day
Date of IRB
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
2017 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032513

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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