Phase 4 N=81 Randomized Treatment

1 Week Versus 6 Weeks of Levetiracetam in Surgical Brain Tumor Patients

Brain Neoplasms · Brain Cancer · Brain Tumors · Cancer of the Brain · Cancer of Brain

Bottom Line

View on ClinicalTrials.gov: NCT02334722 ↗

Enrolled (actual)

Serious AEs

23.7%

Results posted

Dec 2021

Primary outcome: Primary: Change in Neurotoxicity Scale Scores — -1; -3.5 score on scale — p=0.7824

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Levetiracetam (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Florida
Primary completion: Oct 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Neurotoxicity Scale Scores	-1; -3.5	0.7824

Summary

The purpose of this study is to see if there are any differences in patient reported neurotoxicity between patients who receive Levetiracetam tablets for one week after surgery to remove a brain tumor versus those who receive Levetiracetam tablets for six weeks after surgery. Specifically, we will see if one group has less side effects than the other, and whether or not one group has more seizures than the other.

Eligibility Criteria

Inclusion Criteria

Adult (>18 years of age and older) patients who have or will have undergone surgical resection or biopsy of a supratentorial brain tumor and are able to consent for themselves.
Able to be randomized prior to or up to 48 hours after surgery.

Exclusion Criteria

No known history of seizure activity.
Pregnant or breastfeeding.
Renal dysfunction (CrCl < 30ml/min).
Beck's Depression Inventory (BDI) ≥14
Allergy to levetiracetam.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02334722). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.