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Abstract Details

Post Hoc Analysis of Rufinamide Study 022: Adverse Events in Titration vs Maintenance Periods in Patients with Lennox-Gastaut Syndrome
Epilepsy/Clinical Neurophysiology (EEG)
P10 - Poster Session 10 (5:30 PM-6:30 PM)
12-009
To report adverse events (AEs) experienced during the Titration and Maintenence Periods of Study 022, a multicenter, randomized, double-blind, placebo-controlled trial in patients treated with rufinamide with inadequately controlled Lennox-Gastaut Syndrome (LGS).
Rufinamide is indicated for the adjunctive treatment of seizures associated with LGS in pediatric patients aged ≥1 year, and in adults.

The study comprised a 28-day Baseline Phase and an 84-day Double-Blind Treatment Phase (Maintenance Period was 70 days, occurring after a 2-week Titration Period) where patients received rufinamide (100/200/400 mg twice daily) or placebo in addition to their stable dose of 1–3 concomitant anti-seizure medications. During Titration, doses were increased based on weight (forced titration) and the dose at the end of Titration was used during Maintenance. Treatment-emergent AEs (TEAEs) were recorded during both periods.
During Titration, 74 patients were randomized to rufinamide and 64 to placebo. Most common TEAEs during Titration were somnolence and vomiting for rufinamide, and somnolence, pyrexia, and fatigue for placebo. During Maintenance, pyrexia was the most common TEAE (both cohorts). For rufinamide, fewer patients experienced vomiting, somnolence, fatigue, diarrhea, appetite decreased, anorexia, ataxia, and rash during Maintenance vs Titration. Pyrexia increased in both groups from Titration to Maintenance. For placebo, incidence of upper respiratory tract infections and diarrhea increased from Titration to Maintenance. Incidence of nasopharyngitis was similar in Titration and Maintenance Periods for rufinamide, but increased in placebo-treated patients during Maintenance. For rufinamide, mean (standard deviation) time to AE onset (any TEAE) was 22.3 (16.8) days and resolution of AEs during Maintenance was 27.5 (15.1) days; these were 30.3 (17.6) and 34.6 (17.8) days, respectively, for placebo. 

Most AEs experienced by rufinamide-treated patients during Titration were reduced or absent during the Maintenance Period. This suggests that AEs associated with rufinamide are transient and resolve with continued treatment.

Funding: Eisai Inc.
Authors/Disclosures

PRESENTER 		No disclosure on file
Carlos Perdomo (Eisai Inc.) No disclosure on file
Manoj Malhotra, MD Dr. Malhotra has received personal compensation for serving as an employee of Eisai.