NCT05897658
Not yet recruiting
Phase 3
Pilot Study: Levetiracetam Prophylaxis Randomized Controlled Trial in Brain Tumor Resection
Overview
- Phase
- Phase 3
- Intervention
- Levetiracetam
- Conditions
- Seizures
- Sponsor
- Hamilton Health Sciences Corporation
- Enrollment
- 70
- Primary Endpoint
- Recruitment Rate
- Status
- Not yet recruiting
- Last Updated
- last year
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.
Investigators
Eligibility Criteria
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)
Levetiracetam 1 g taken orally twice a day for 7 days
Intervention: Levetiracetam
Placebo
Placebo taken orally twice a day for 7 days
Intervention: Placebo
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)
Similar Trials
Recruiting
Not Applicable
Low Concentration Atropine in the Prevention of Myopia in Children.Myopia, ProgressiveNCT05939882Shanghai Eye Disease Prevention and Treatment Center428
Completed
Not Applicable
L. Reuteri DSM 17938 and L. Reuteri ATCC PTA 6475 in Moderate to Severe Irritable Bowel in AdultsIrritable Bowel SyndromeNCT04037826Innovacion y Desarrollo de Estrategias en Salud140
Completed
Phase 2
To Evaluate the Efficacy and Safety of LO2A Eye Drops in Patients With ConjunctivochalasisConjunctivochalasisNCT02810119Ocuwize LTD13
Completed
Phase 4
Preemptive and Preventive Use of Paracetamol for Pain Relief After Cesarean SectionCesarean Section; DehiscenceNCT02714179Baskent University54
Terminated
Phase 2
Trial of Lovaza in Adolescents With Mild to Moderately Elevated TriglyceridesHypertriglyceridemiaNCT00672633Boston Children's Hospital25