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 | 2026/04/01 10:29:15 |
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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
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
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
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
https://pubmed.ncbi.nlm.nih.gov/35698711/
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/35698711/
Number of participants that the trial has enrolled
53
Results
This randomized trial compared LEV alone with LEV plus sodium channel blockers to assess safety and early seizure prevention. Forty-nine patients undergoing craniotomy or biopsy were analyzed. Seizures occurred less frequently in the combination group than in the LEV-only group within one and two weeks after surgery, though differences were not statistically significant. Adverse events were similar across groups, and no hepatic or renal dysfunction occurred with lacosamide.
Results date posted
| 2026 | Year | 04 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 05 | Month | 10 | Day |
Baseline Characteristics
Background Brain tumor patients tend to develop postoperative epileptic seizures, which can lead to an unfavorable outcome. Although the incidence of postoperative epileptic seizures and adverse events are improved with the advent of levetiracetam (LEV), postoperative epilepsy occurs at a frequency of 4.6% or higher. In brain tumor patients, the addition of sodium channel blockers (SCBs) to LEV significantly reduces seizures, though confirmed in a non-postoperative study. Thus, the combination of SCBs with LEV might be promising.
Objective In this prospective randomized controlled trial we investigated the safety, evaluated by adverse events during one and two weeks after surgery, and the efficacy, evaluated by the incidence of early epilepsy, including non-convulsive status epilepticus (NCSE), of using LEV alone or SCBs added to LEV in patients who underwent craniotomy or biopsy for brain tumors or brain mass lesions.
Participant flow
Methods Patients with brain tumors or brain mass lesions undergoing surgical interventions, excluding endoscopic endonasal surgery (EES), with a diagnosis of epilepsy were eligible for this study. Patients are randomized into either Group A or B (B1 or B2) after the informed consents are taken; LEV alone in Group A patients, while LEV and SCBs in Group B patients (GroupB1, intravenous fosphenytoin plus oral lacosamide (LCM) and GroupB2, intravenous LCM plus oral LCM) were administered postoperatively. Fifty-three patients were enrolled during the first two and a half years of the study and four of them were excluded, resulting in the accumulation of 49 patients' data.
Adverse events
Results Postoperative epileptic seizures occurred only in three out of 49 patients during the first week (6.1%) and in seven patients within two weeks after surgery (14.3%, including the three patients during the first week). In Group A, epileptic seizures occurred in two out of 26 patients during the first week (7.7%) and in five patients within two weeks (19.2%) after surgery. In Group B, epileptic seizures occurred in one out of 23 patients during the first week (4.3%) and in two patients during the first two weeks (8.7%). Low complication grade of epileptic seizures was observed in Group B rather than in Group A, however, without significant difference (p=0.256). There was no difference in the frequency of adverse effects in each group.
Outcome measures
Conclusion Although not statistically significant, the incidence of epileptic seizures within one week after surgery was lesser in LEV+SCBs groups than in LEV alone. No hepatic damage or renal function worsening occurred with the addition of LCM, suggesting the safety of LEV+SCBs therapy.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2026 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036368
