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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010552
Receipt No. 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

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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
Email

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
Email mirage10261976@mac.com

Sponsor
Institute Department of Emergency and Critical Care Medicine, Wakayama Medical University
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012337

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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