UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031896
Receipt No. 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 2018/10/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Eiichi Ishikawa
Organization University of Tsukuba
Division name Department of Neurosurgery
Zip code
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
Middle name
Last name Eiichi Ishikawa
Organization University of Tsukuba
Division name Department of Neurosurgery
Zip code
Address Tennodai 1-1-1, Tsukuba, Ibaraki, Japan
TEL 029-853-3220
Homepage URL
Email e-ishikawa@md.tsukuba.ac.jp

Sponsor
Institute Department of Neurosurgery, University of Tsukuba
Institute
Department

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
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 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
Anticipated trial start date
2018 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 26 Day
Last modified on
2018 Year 10 Month 06 Day


Link to view the page
URL(English) https://upload.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


Contact us.