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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name