Prospective, multicenter, single-arm, non-interventional study with a 6-month observation period (EP0045; NCT02276053). LCM was added to existing treatment with 1 or 2 AEDs. Patients aged ≥16 years with BTRE secondary to low-grade glioma (WHO Grade I-II) were eligible. Primary endpoints: percentage of patients experiencing a ≥50% reduction in seizure frequency from Baseline to Month 6; Patient’s Global Impression of Change (PGIC) rating at Month 6. Secondary endpoints: Kaplan-Meier estimated retention rate and change from Baseline in quality-of-life to Month 6 (EQ-5D-5L and MDASI-BT). Safety variables: occurrence of adverse drug reactions (ADRs) and ADRs leading to discontinuation.

93 patients started LCM (mean [SD] age: 44.5 [14.7] years; 54% male); 14 (15%) patients withdrew from the study by 6 months. At 6-months, 71% of all patients had noted ≥50% reduction in seizures, 32% of whom were seizure free. Improvements on PGIC were reported by 53% of all patients. The estimated 6-month retention rate was 86%. Quality of life (EQ-5D-5L) and symptoms outcome measures (MDASI-BT) remained stable. ADRs leading to discontinuation occurred in 4.3% of patients, most commonly vertigo (2.2%).   

This is the first prospective, multicenter study focusing on epilepsy due to homogenous low grade gliomas treated with LCM. The results suggest that LCM reduces seizures in patients with resistant BTRE. The majority of patients noticed a clinical improvement with the addition of LCM. Observed ADRs were consistent with the known safety profile of LCM.