Seizures in patients with suspected cerebral glioma MedDRA version: 20.0 Level: PT Classification code 10018338 Term: Glioma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10061030 Term: Brain tumour System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Keppra
Product Name: Keppra
Product Code: ucb 22059
Pharmaceutical Form: Tablet
INN or Proposed INN: Levetiracetam
CAS Number: 102767-28-2
Concentration unit: mg milligram(s)
Concentration
Sponsors
Common Services Agency
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with suspected cerebral glioma on MRI ?2)Capable of giving informed consent ?3)Patients must be = 16 years old ?4)Patients must have a Karnofsky performance status =70 ?5)Patients must be able to safely swallow pills 6)Planned surgery for presumed glioma (biopsy or resection) Are the trial subjects under 18? yes Number of subjects for this age range: 8 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 474 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 322
Exclusion criteria
Exclusion criteria: 1)Pregnant 2)History of any type of seizure for at least 10 years prior to randomisation ?3)Known Severe Chronic Kidney Disease (CKD4 - eGFR < 30ml/min) 4)Concomitant methotrexate 5)Concomitant AED (including use for other reasons (e.g. pain)) 6)Concomitant benzodiazepines 7)Hypersensitivity to levetiracetam
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This aim of the study is to investigate whether use of levetiracetam before surgery will help to prevent patients with suspected brain tumours developing seizures after their surgery. The patients will have surgery planned and will have not experienced a seizure. We will give half of these patients current standard care (no anti-epileptic drug) and the other half will receive an anti epileptic drug called levetiracetam before surgery and for up to one year after to see if this drug will reduce their risk of having seizures. Using a drug in this manner is called prophylactic use. ;Secondary Objective: In patients with a suspected brain tumour, that have never had a seizure, does taking preventative (taken before any seizure) levetiracetam: • Delay the time for a patient to have their first seizure. • Delay the time for a patient to have their first tonic-clonic (or convulsive) seizure. • Have any affect on patients’ mood, personality, energy levels (tiredness) or memory. • Have any effect on how the severe the first seizure is if it happens. • Have an impact on the patients quality of life (wellbeing ) • Have an impact on a patient’s survival without cancer relapse. • Have an impact on a patient’s survival. • Reduces costs to the NHS and personal social services (PSS) over the 12 months trial follow-up. In addition the study will investigate if taking preventative (taken before any seizure) levetiracetam is cost effective. The cost effectiveness will be measured by looking at cost change per Quality adjusted life year (QALY) over a 12 month period. A Quality adjusted life year is ;Primary end point(s): Primary Outcome is one year risk of first seizure. ;Timepoint(s) of evaluation of this end point: Evaluated at clinic visits at 3, 6, 9 and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time to first seizure Time to first tonic clonic seizure Mood, personality, fatigue and memory Severity of first seizure Quality of life Progression free survival Overall survival Costs to the NHS (National Health Service) and personal social services (PSS) cost-effectiveness ;Timepoint(s) of evaluation of this end point: Evaluated at clinic visits at 3, 6, 9 and 12 months and through monthly telephone calls from a research nurse. | — |
Countries
United Kingdom
Contacts
Public ContactEve Macdonald Chisholm
Scottish Clinical Trials Research Unit
Outcome results
None listed