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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008606
Receipt No. 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

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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
Email 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
Email tkik@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Neurosurgery, Kyoto University Hospital
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010111

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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