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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000031896

Enrollment

235

Registered

2018-03-30

Start date

2018-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain tumors

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Incidence of post-operative epileptic seizures within 2 weeks after brain tumor surgery	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactEiichi Ishikawa

University of Tsukuba Department of Neurosurgery

e-ishikawa@md.tsukuba.ac.jp029-853-3220

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026