Levetiracetam Prophylaxis in Brain Tumor Resection Pilot
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHamilton Health Sciences Corporation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult age 18 years or older
Undergoing craniotomy for a brain tumor
Intra-axial tumor location
Supratentorial tumor location
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Levetiracetam
DrugTablets
Placebo
Other interventionTablets
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Seizure Prophylaxis (Levetiracetam)Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment Rate
Feasibility outcome
Time frame
Through study completion, approximately 1 yearSecondary outcomes
1
Fraction of eligible patients approached
Time frame
Through study completion, approximately 1 year2
Fraction of approached patients consent
Time frame
Through study completion, approximately 1 year3
Role of individual who approached patients
Description of research team member first approaching and consenting patients (e.g. resident, research staff, staff surgeon, etc.)
Time frame
Through study completion, approximately 1 year4
Protocol adherence
Number of participants who withdrawal from the study
Time frame
Through study completion, approximately 1 yearOther outcomes
1
New onset seizure within 7 days of surgery
Time frame
7 days post-surgery, reviewed at follow-up between post-operative day 8 and 142
Incidence of infection during Study Drug administration
Time frame
Follow-up between post-operative day 8 and 143
Incidence of psychiatric symptoms during Study Drug Administration
Time frame
Follow-up between post-operative day 8 and 144
Length of hospital stay in days
Time frame
Hospital dischargeLocations
Sponsors and contacts
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Hamilton Health Sciences Corporation
Lead sponsor
McMaster University
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: