Vimpat vs. Placebo Study
Determines Risk of Seizures
Accrual is currently on hold.
This study’s primary objective is to determine if prophylactic administration of lacosamide reduces the risk of seizures in patients with a high-grade glioma. Newly diagnosed, post-operative patients are tested during the first year after tumor diagnosis.
The secondary objective is to determine the one-year risk of first seizure among the patients to evaluate patient-reported symptoms.
Patient eligibility criteria:
- Patients with historically confirmed supratentorial high-grade glioma will be eligible for this protocol
- All patients must sign an informed consent form indicating that they are aware of the investigational nature of this study
- Patients must be older than 18
- Patients must have a Karnofsky Performance Scale Index of greater than 60
- Women of childbearing potential must have a negative β-HCG pregnancy test documented within two weeks of registration
- In the opinion of the treating investigator, patients must have adequate cognitive abilities to complete the neurocognitive components of the study
- Patients must be able to safely swallow pills