UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Levetiracetam versus phenytoin for seizure prophylaxis during and early after craniotomy for brain tumours: A phase II, prospective, randomised study
Title of the study (Brief title)	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	Toshihiko Iuchi
Organization	Chiba Cancer Center
Division name	Division of Neurological Surgery
Address	666-2 Nitona-cho, Chuo-ku, Chiba, Japan
TEL	043-264-5431
Email	tiuchi@chiba-cc.jp

Public contact
Name of contact person	Toshihiko Iuchi
Organization	Chiba Cancer Center
Division name	Division of Neurological Surgery
Address	666-2 Nitona-cho, Chuo-ku, Chiba, Japan
TEL	043-264-5431
Homepage URL
Email	tiuchi@chiba-cc.jp

Sponsor
Institute	Division of Neurological Surgery, Chiba Cancer Center
Institute
Department

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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 03 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016276