Vimpat vs. Placebo Study
Determines Risk of Seizures
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