Levetiracetam Prophylaxis in Brain Tumor Resection Pilot (LeviTaTe Pilot)

Hamilton Health Sciences (HHS)

Status and phase: Not yet enrolling; Phase 3

Conditions: Seizures; Brain Tumor

Treatments: Other: Placebo; Drug: Levetiracetam

Study type: Interventional

Funder types: Other

Identifiers

NCT05897658

14147

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

70 participants in 2 patient groups, including a placebo group

Seizure Prophylaxis (Levetiracetam)

Experimental group

Description:

Levetiracetam 1 g taken orally twice a day for 7 days

Treatment:

Drug: Levetiracetam

Placebo

Placebo Comparator group

Description:

Placebo taken orally twice a day for 7 days

Treatment:

Other: Placebo