UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008606 |
|---|---|
| Receipt number | R000010111 |
| Scientific Title | Clinical research on perioperative antiepileptic treatment for brain tumor cases |
| Date of disclosure of the study information | 2012/09/01 |
| Last modified on | 2020/09/25 19:57:28 |
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Basic information
Public title
Clinical research on perioperative antiepileptic treatment for brain tumor cases
Acronym
Clinical research on perioperative antiepileptic treatment for brain tumor cases
Scientific Title
Clinical research on perioperative antiepileptic treatment for brain tumor cases
Scientific Title:Acronym
Clinical research on perioperative antiepileptic treatment for brain tumor cases
Region
| Japan |
Condition
Condition
Surgical cases of brain tumor treated with antiepileptic drugs (AEDs)
Classification by specialty
| Neurology | Neurosurgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In order to clarify the efficacy, safety, durability of newly approved antiepileptic drug, surgical cases of brain tumor will be treated peri-operatively with monotherapy of Levetiracetam (LEV), instead of commonly used drug Zonisamide (ZNS), Seizure control on, incidence of adverse event with, and probability of remaining on LEV will be compared with ZNS, based on the postoperative data of 6 months follow-up period.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Seizure control, up to 6 months after surgical treatment
Incidence of unacceptable adverse events
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
Interventions/Control_2
Zonisamide
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
Any surgical adult case of supratentorial brain tumor, who needs antiepileptic treatment due to past history of seizure and/or abnormal findings on electroencephalography, will be included based on his/her informed consent
Key exclusion criteria
The patient, who is on pregnancy and lactation period, with severely impaired liver function, with renal dysfunction (CCre<50), who needs two or more antiepileptic drugs for seizure control, who has more than one generalized seizure a day, who has past history of interstitial irradiation, who has life expectancy less than six months, who cannot take oral medication, who has Karnofsky Performance Score <70, who has hypersensitivity to the designated medicine and/or pyrrolidone derivative, who disagree with this research, who has brain tumor only in the posterior fossa, or who does not have surgical indication for tumor, will be excluded.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Susumu Miyamoto |
Organization
Kyoto University Hospital
Division name
Department of Neurosurgery
Zip code
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3459
miy@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Kikuchi |
Organization
Kyoto University Hospital
Division name
Department of Neurosurgery
Zip code
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3459
Homepage URL
tkik@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Neurosurgery, Kyoto University Hospital
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2012 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2012 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2017 | Year | 10 | 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
| 2012 | Year | 08 | Month | 02 | Day |
Last modified on
| 2020 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010111
