Perioperative Levetiracetam for seizure prophylaxis in brain tumor patients. Prospective evaluation of side effects and efficacy

Perioperative Levetiracetam for seizure prophylaxis in brain tumor patients. Prospective evaluation of side effects and efficacy - LAHENE Study

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003916-19-AT

Enrollment

100

Registered

2015-11-25

Start date

2015-12-30

Completion date

Unknown

Last updated

2016-01-11

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

Conditions

Data on perioperative seizure prophylaxis in brain tumor patients as weil as on specific side effects is limited in scientific literature. Epileptic seizures during and after brain tumor surgery may lead to severe complication as tor example intracranial hypertension, brain herniation and neurologie impairment. Aim of this study is the evaluation of efficacy and side effects of Levetiracetam in perioperative seizure prophylaxis in patients suffering trom brain tumors.

Interventions

Trade Name: Keppra Product Name: Levetiracetam Product Code: EMEA/H/C/000277-R/0154 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: LEVETIRACETAM CAS Number: 102767-28-2 Concentration uni

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: adult patients (age 18-90) planned to undergo brain surgery because of supratentorial brain tumor Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: Contraindication against Levetiracetam , preexisting anticonvulsive medication

Design outcomes

Primary

Measure	Time frame
Main Objective: Aim of this study is the evaluation of efficacy and side effects of levetiracetam in perioperative seizure prophylaxis in patients suffering from brain tumors (Definition of perioperative: 3 days preoperative until 7 days postoperativ). Levetiracetam has the approval for treatment of patients suffering from epilepsie as first line therapy. Levetiracetam has no approval in the setting of perioperative seizure prophylaxis. The data obtained in this pilotstudy may serve as basis tor a future study comparing the the efficacy and drug tolerability of levetiracetam versus lacosamid in perioperative seizure prophylaxis in brain tumor patients.;Secondary Objective: medication specific side effects;Primary end point(s): Occurence of epileptic seizures;Timepoint(s) of evaluation of this end point: baseline examination (before onset of Levetiraeetam ) examination 1 (2-3 days after onset of Levetiracetam) examination 2( 7-10 days after surgery) examination 3 (follow up, 3-4 weeks after surgery)	—

Measure

Time frame

Main Objective: Aim of this study is the evaluation of efficacy and side effects of levetiracetam in perioperative seizure prophylaxis in patients suffering from brain tumors (Definition of perioperative: 3 days preoperative until 7 days postoperativ). Levetiracetam has the approval for treatment of patients suffering from epilepsie as first line therapy. Levetiracetam has no approval in the setting of perioperative seizure prophylaxis. The data obtained in this pilotstudy may serve as basis tor a future study comparing the the efficacy and drug tolerability of levetiracetam versus lacosamid in perioperative seizure prophylaxis in brain tumor patients.;Secondary Objective: medication specific side effects;Primary end point(s): Occurence of epileptic seizures;Timepoint(s) of evaluation of this end point: baseline examination (before onset of Levetiraeetam ) examination 1 (2-3 days after onset of Levetiracetam) examination 2( 7-10 days after surgery) examination 3 (follow up, 3-4 weeks after surgery)

—

Secondary

Measure	Time frame
Secondary end point(s): Medication side effects;Timepoint(s) of evaluation of this end point: baseline examination (before onset of Levetiraeetam ) examination 1 (2-3 days after onset of Levetiracetam) examination 2( 7-10 days after surgery) examination 3 (follow up, 3-4 weeks after surgery)	—

Countries

Austria

Contacts

Public ContactUniversity clinic St. Pölten

Karl Landsteiner Institut für klinische Neurologie und Neuropsychologie

Stefan.Oberndorfer@stpoelten.lknoe.at004327429004 15606

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026