E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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E.1.1.1 | Medical condition in easily understood language |
Aim of this study is the evaluation of efficacy and side effects of Levetiracetam in perioperative seizure prophylaxis in patients suffering trom brain tumors. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
medication specific side effects |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
adult patients (age 18-90) planned to undergo brain surgery because of supratentorial brain tumor |
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E.4 | Principal exclusion criteria |
Contraindication against Levetiracetam , preexisting anticonvulsive medication |
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E.5 End points |
E.5.1 | Primary end point(s) |
Occurence of epileptic seizures |
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E.5.1.1 | 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) |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | 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) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
prospective, monocentric, non- randomized phase II interventional pilot study |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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planned sample size of 100 patients Interim analysis at a sample size of 50 patients, termination of the study if side effects occur that significantly exceed the epilepsy-population side effects |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |