A Two-Part Study of ZX008 in Children and Adults with Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults with LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults with LGS
To evaluate the effect of ZX008 0.8 mg/kg/day versus placebo as adjunctive therapy for the treatment of uncontrolled seizures in children and adults with Lennox-Gastaut syndrome (LGS) based on the change in frequency of seizures that result in drops between baseline and the combined Titration and Maintenance Periods (T+M) The primary objective of Part 2 is: To assess the long-term safety and tolerability of ZX008 in children and adults with LGS with regard to adverse events (aes), laboratory parameters, physical examination, neurological examination, suicidality, cognition (BRieF), vital signs (blood pressure, heart rate, temperature, and respiratory rate), electrocardiograms (eCG), echocardiograms (eCHo), body weight, and BMi.
