UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031896
Receipt number R000036368
Scientific Title A randomized phase IIb study comparing levetiracetam alone with lacosamide add-on for reduction of epileptic seizure after brain tumor surgery
Date of disclosure of the study information 2018/03/30
Last modified on 2020/09/27 16:17:36

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Basic information

Public title

A randomized phase IIb study comparing levetiracetam alone with lacosamide add-on for reduction of epileptic seizure after brain tumor surgery

Acronym

CLEAR-EPI study

Scientific Title

A randomized phase IIb study comparing levetiracetam alone with lacosamide add-on for reduction of epileptic seizure after brain tumor surgery

Scientific Title:Acronym

CLEAR-EPI study

Region

Japan


Condition

Condition

Brain tumors

Classification by specialty

Neurosurgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate incidence of post-operative epileptic seizures and adverse effects in brain tumor patients with levetiracetam alone or levetiracetam plus lacosamide after surgery.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Incidence of post-operative epileptic seizures within 2 weeks after brain tumor surgery

Key secondary outcomes

Incidence of anti-epileptic drug-related adverse effects and nonconvulsive status epilepticus (NCSE) within 2 weeks after brain tumor surgery
Incidence of post-operative epileptic seizures and anti-epileptic drug-related adverse effects in follow-up period after brain tumor surgery


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Anti-epileptic drug, levetiracetam (LEV)

Interventions/Control_2

Anti-epileptic drugs, levetiracetam (LEV) plus lacosamide (LCM) (plus fos-phenytoin (fPHT))

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

99 years-old >=

Gender

Male and Female

Key inclusion criteria

1) a brain tumor patient who will undergo surgical intervention (excluding trans-sphenoidal surgery)

2) a patient who has a past-history of epileptic seizure

Key exclusion criteria

1) a patient who has a past-history of severe adverse effect due to LEV, PHT, fPHT or LCM
2) a patient who is treated with intra-venous LEV, fPHT or LCM
3) a patient who is treated with oral PHT or LCM

Target sample size

235


Research contact person

Name of lead principal investigator

1st name Eiichi
Middle name
Last name Ishikawa

Organization

University of Tsukuba

Division name

Department of Neurosurgery

Zip code

305-8575

Address

Tennodai 1-1-1, Tsukuba, Ibaraki, Japan

TEL

029-853-3220

Email

e-ishikawa@md.tsukuba.ac.jp


Public contact

Name of contact person

1st name Eiichi
Middle name
Last name Ishikawa

Organization

University of Tsukuba

Division name

Department of Neurosurgery

Zip code

305-8575

Address

Tennodai 1-1-1, Tsukuba, Ibaraki, Japan

TEL

029-853-3220

Homepage URL


Email

e-ishikawa@md.tsukuba.ac.jp


Sponsor or person

Institute

Department of Neurosurgery, University of Tsukuba

Institute

Department

Personal name



Funding Source

Organization

Department of Neurosurgery, University of Tsukuba

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

institutional review board in University of Tsukuba Hospital

Address

Tennodai 1-1-1, Tsukuba, Ibaraki, Japan

Tel

029-853-3914

Email

rinshokenkyu@un.tsukuba.ac.jp


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

筑波大学附属病院(茨城県)


Other administrative information

Date of disclosure of the study information

2018 Year 03 Month 30 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

Enrolling by invitation

Date of protocol fixation

2018 Year 03 Month 22 Day

Date of IRB

2018 Year 03 Month 29 Day

Anticipated trial start date

2018 Year 05 Month 01 Day

Last follow-up date

2023 Year 01 Month 14 Day

Date of closure to data entry

2023 Year 01 Month 31 Day

Date trial data considered complete

2023 Year 03 Month 31 Day

Date analysis concluded

2023 Year 05 Month 01 Day


Other

Other related information



Management information

Registered date

2018 Year 03 Month 26 Day

Last modified on

2020 Year 09 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036368


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name