NCT01432171

Lacosamide in Preventing Seizures in Participants With Malignant Glioma

Randomized, Double-Blind, Placebo-Controlled Trial of Lacosamide for Seizure Prophylaxis in Patients With High-Grade Gliomas

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial studies how well lacosamide works in preventing seizures in participants with malignant glioma. Anti-seizure drugs, such as lacosamide, may decrease abnormal electrical activity in the brain that plays a role in developing seizures.

Detailed description

PRIMARY OBJECTIVES: I. To determine if prophylactic administration of Lacosamide reduces the risk of seizures in patients with high-grade glioma (HGG). SECONDARY OBJECTIVES: I. To determine the one-year risk of first seizure in this patient population. II. To evaluate patient reported symptoms. EXPLORATORY OBJECTIVES: I. To investigate clinical and electroencephalographic predictors of seizures in this patient population. II. To evaluate the occurrence of symptoms and correlate to seizure activity as well as tolerance to treatment using the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) self-reporting tool. OUTLINE: Participants are randomized to 1 of 2 arms. ARM I (LACOSAMIDE): Participants receive lacosamide orally (PO) twice a day (BID) for up to 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity. ARM II (PLACEBO): Participants receive a placebo PO BID for up to 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, participants are followed up every 3 months for 5 years.

Conditions

• Malignant Glioma

Interventions

Type	Name	Description
DRUG	Lacosamide	Given PO
OTHER	Placebo	Given PO

Timeline

• Start date: 2012-07-25
• Primary completion: 2017-06-20
• Completion: 2017-06-20
• First posted: 2011-09-12
• Last updated: 2018-12-19
• Results posted: 2018-12-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study