NCT05897658Not yet recruitingPhase 3
Pilot Study: Levetiracetam Prophylaxis Randomized Controlled Trial in Brain Tumor Resection
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Enrollment
- 70
- Primary Endpoint
- Recruitment Rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Seizure Prophylaxis (Levetiracetam)
Experimental
Levetiracetam 1 g taken orally twice a day for 7 days
Intervention: Levetiracetam (Drug)
Placebo
Placebo Comparator
Placebo taken orally twice a day for 7 days
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Recruitment Rate
Time Frame: Through study completion, approximately 1 year
Feasibility outcome
Secondary Outcomes
- 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)
- Protocol adherence(Through study completion, approximately 1 year)
- Adverse events(Through study completion, approximately 1 year)
- Unblinding events(Through study completion, approximately 1 year)
Investigators
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