UMIN-CTR Clinical Trial

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