UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010552 |
|---|---|
| Receipt number | R000012337 |
| Scientific Title | Study on efficacy and safety of levetiracetam administration by nasogastric tube in patients with convulsive status epilepticus |
| Date of disclosure of the study information | 2013/04/21 |
| Last modified on | 2014/10/07 14:46:37 |
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Basic information
Public title
Study on efficacy and safety of levetiracetam administration by nasogastric tube in patients with convulsive status epilepticus
Acronym
Levetiracetam administration by nasogastric tube in convulsive status epilepticus
Scientific Title
Study on efficacy and safety of levetiracetam administration by nasogastric tube in patients with convulsive status epilepticus
Scientific Title:Acronym
Levetiracetam administration by nasogastric tube in convulsive status epilepticus
Region
| Japan |
Condition
Condition
Convulsive 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 efficacy and safety of levetiracetam administration by the nasogastric tube in patients with convulsive status epilepticus
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Disappearance of convulsion within 30 min after administration
Key secondary outcomes
Seizure free period of 3-day after administration
Side effects
Mortality
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Levetiracetam administration by the nasogastric tube to patients after convulsion disappeared with diazepam i.v.
Interventions/Control_2
Levetiracetam administration by the nasogastric tube to patients with convulsion lasting after diazepam i.v.
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with convulsive status epilepticus who can be administered by the nasogastric tube
Key exclusion criteria
Patinets with non-convulsive status epilepticus
Patients required administration of sedative with anticonvulsive effect
Systolic blood pressure <60mmHg, >=220mmHg
Heart rate <40/min, >=150/min
Respiration rate <5/min, >=40/min
SpO2 <89%
Unstable state of airway
Acute coronary syndrome
Active gastrointestinal bleeding
Patients required intermittent hemodialysis or continuous renal replacement therapy
Levetiracetam allergy
Patients considered as inappropriate to participate in this study by attending physicians
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takafumi Yonemitsu |
Organization
Wakayama Medical University
Division name
Department of Emergency and Critical Care Medicine
Zip code
Address
811-1 Kimiidera, Wakayama-shi, Wakayama-ken, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takafumi Yonemitsu |
Organization
Wakayama Medical University
Division name
Department of Emergency and Critical Care Medicine
Zip code
Address
811-1 Kimiidera, Wakayama-shi, Wakayama-ken, Japan
TEL
Homepage URL
mirage10261976@mac.com
Sponsor or person
Institute
Department of Emergency and Critical Care Medicine, Wakayama Medical University
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
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
和歌山県立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 21 | 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
Completed
Date of protocol fixation
| 2013 | Year | 04 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2014 | Year | 04 | Month | 20 | Day |
Date of closure to data entry
| 2014 | Year | 10 | Month | 20 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 21 | Day |
Last modified on
| 2014 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012337
| 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 |
