Zogenix completes enrollment in Phase 3 trial of FINTEPLA
Zogenix announced that it has completed enrollment for, and randomized the last patient into the treatment period of, Study 1601, the Company's Phase 3 clinical trial of its lead investigational therapy, FINTEPLA, for the treatment of seizures associated with Lennox-Gastaut Syndrome, a severe and often treatment-resistant childhood-onset epilepsy. Study 1601 is a multi-national, randomized, double-blind, placebo-controlled trial of two fixed doses of FINTEPLA as adjunctive therapy for seizures in children and adults with LGS. After establishing a baseline seizure frequency for four weeks, patients are randomized into one of three treatment group for a two-week period of dose titration before being held at a fixed dose for 12 weeks of maintenance treatment. The study randomized a total of 263 patients, with approximately 87 subjects per group. The primary endpoint of the clinical trial is the change in the number of seizures that result in drops between baseline and the combined titration and maintenance periods at the 0.8 mg/kg/day dose compared to placebo. The key secondary endpoints include change in the number of drop seizures between baseline and the combined titration and maintenance periods at the 0.2 mg/kg/day dose compared to placebo, and the proportion of patients achieving a 50% reduction in drop seizures. Patients who complete the maintenance treatment period may be eligible to enter a 12-month open-label extension to evaluate the long-term safety, tolerability and effectiveness of FINTEPLA in LGS. FINTEPLA for the treatment of LGS has previously been designated as an orphan drug by both the U.S. Food and Drug Administration and the European Medicines Agency.