UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013971 |
|---|---|
| Receipt number | R000016276 |
| Scientific Title | Levetiracetam versus phenytoin for seizure prophylaxis during and early after craniotomy for brain tumours: A phase II, prospective, randomised study |
| Date of disclosure of the study information | 2014/05/16 |
| Last modified on | 2018/04/09 08:02:38 |
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Basic information
Public title
Levetiracetam versus phenytoin for seizure prophylaxis during and early after craniotomy for brain tumours: A phase II, prospective, randomised study
Acronym
LPBTSP
Scientific Title
Levetiracetam versus phenytoin for seizure prophylaxis during and early after craniotomy for brain tumours: A phase II, prospective, randomised study
Scientific Title:Acronym
LPBTSP
Region
| Japan |
Condition
Condition
supratentrial brain tumor
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the effect of levetiracetam on seizure prophylaxis in the perioperative period in comparison with phenytoin
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
occurrence of seizure in the perioperative period
Key secondary outcomes
occurrence of hematological and non-hematological adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
levetiracetam
Interventions/Control_2
phenytoin
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with supratentrial brain tumor that required craniotomy, and with adequate hepatic and renal function
Key exclusion criteria
patients who had a history of seizures that were uncontrollable by LEV or PHT
Patients with known allergy to any of the study medications
pregnancy
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiko Iuchi |
Organization
Chiba Cancer Center
Division name
Division of Neurological Surgery
Zip code
Address
666-2 Nitona-cho, Chuo-ku, Chiba, Japan
TEL
043-264-5431
tiuchi@chiba-cc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiko Iuchi |
Organization
Chiba Cancer Center
Division name
Division of Neurological Surgery
Zip code
Address
666-2 Nitona-cho, Chuo-ku, Chiba, Japan
TEL
043-264-5431
Homepage URL
tiuchi@chiba-cc.jp
Sponsor or person
Institute
Division of Neurological Surgery, Chiba Cancer Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
千葉県がんセンター（千葉県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 16 | 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 | 03 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 16 | Day |
Last modified on
| 2018 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016276
