Brain Tumor, Seizures
Conditions
Brief summary
This study aims to evaluate feasibility of a double-blind randomized controlled trial for levetiracetam prophylaxis for prevention of seizure in the perioperative phase of brain tumor resection.
Interventions
DRUGLevetiracetam
Tablets
OTHERPlacebo
Tablets
Sponsors
McMaster University
Hamilton Health Sciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult age 18 years or older * Undergoing craniotomy for a brain tumor * Intra-axial tumor location * Supratentorial tumor location
Exclusion criteria
* Documented seizure history or epilepsy diagnosis * Currently taking an antiepileptic medication * Unable to take levetiracetam (e.g. allergy, inability to swallow) * Inability to obtain consent from participant or substitute decision maker prior to surgery * Renal impairment with eGFR less than 50 * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | Through study completion, approximately 1 year | Feasibility outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fraction of eligible patients approached | Through study completion, approximately 1 year | — |
| Fraction of approached patients consent | Through study completion, approximately 1 year | — |
| Role of individual who approached patients | Through study completion, approximately 1 year | Description of research team member first approaching and consenting patients (e.g. resident, research staff, staff surgeon, etc.) |
| Protocol adherence | Through study completion, approximately 1 year | Number of participants who withdrawal from the study |
| Adverse events | Through study completion, approximately 1 year | Serious and related adverse events and adverse drug reactions |
| Unblinding events | Through study completion, approximately 1 year | Number of events and reasoning |
Other
| Measure | Time frame |
|---|---|
| Incidence of infection during Study Drug administration | Follow-up between post-operative day 8 and 14 |
| Incidence of psychiatric symptoms during Study Drug Administration | Follow-up between post-operative day 8 and 14 |
| Length of hospital stay in days | Hospital discharge |
| Incidence of administration of any antiepileptic drugs | Follow-up between post-operative day 8 and 14 |
| Incidence of administration of any benzodiazepines | Follow-up between post-operative day 8 and 14 |
| New onset seizure within 7 days of surgery | 7 days post-surgery, reviewed at follow-up between post-operative day 8 and 14 |
Contacts
Primary ContactTaylor Duda, MD
Backup ContactAmanda Martyniuk, MSc
Outcome results
None listed