UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009984 |
|---|---|
| Receipt number | R000011685 |
| Scientific Title | Efficacy and safety of levetiracetam therapy for early postoperative seizures following brain tumor surgery |
| Date of disclosure of the study information | 2013/02/08 |
| Last modified on | 2015/07/08 19:25:08 |
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Basic information
Public title
Efficacy and safety of levetiracetam therapy for early postoperative seizures following brain tumor surgery
Acronym
Efficacy of levetiracetam for early postoperative seizures following brain tumor surgery
Scientific Title
Efficacy and safety of levetiracetam therapy for early postoperative seizures following brain tumor surgery
Scientific Title:Acronym
Efficacy of levetiracetam for early postoperative seizures following brain tumor surgery
Region
| Japan |
Condition
Condition
early postoperative seizures following brain tumor surgery
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the efficacy and safety of levetiracetam therapy for early postoperative seizure control following brain tumor surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
occurence of seizures at 1 week postoperation
Key secondary outcomes
adverse drug events due to levetiracetam
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Levetiracetam (500 mg twice a day) is administered orally to brain tumor patients with epilepsy for preoperative 1-3 days. Phenytoin (250-500 mg) or fosphenytoin (375-750 mg) is administered intravenously to the patients on the postoperative day 0 (POD0). Phenytoin (250 mg) or fosphenytoin (375 mg) is administered intravenously to the patients on POD1. The oral regimen of levetiracetam (500 mg twice a day) starts within 36 h of surgery and continues until POD7.
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
Seizure history attributable to brain tumor, planned intracranial surgery as standard management, aged 20 and over
Key exclusion criteria
Pregnancy or breast- feeding, allergy to levetiracetam, severe liver or renal dyfunction
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Nozaki |
Organization
Shiga University of Medical Science
Division name
Neurosurgery
Zip code
Address
Setatsukinowacho, Otsu, Shiga, Japan
TEL
0775482257
noz@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Nitta |
Organization
Shiga University of Medical Science
Division name
Neurosurgery
Zip code
Address
Setatsukinowacho, Otsu, Shiga, Japan
TEL
077-548-2257
Homepage URL
nnitta@belle.shiga-med.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Department of Neurosurgery, Shiga University of Medical Science
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
滋賀医科大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 08 | 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
| 2012 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 06 | Day |
Last modified on
| 2015 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011685
