Enrolling Now - 5
ZX008-1601
Study Title: 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
Sponsor: Zogenix International Limited
PI: Eric Segal, MD
SELECTION CRITERIA FOR PART 1:
* Male or non-pregnant, non-lactating female Female between the age 2 to 35 inclusive
* Subject must have a diagnosis of Lennox-Gastaut Syndrome, where seizures that results in drops are not completely controlled by current antiepileptic treatments.
* Subjects must meet all of the following criteria:
a. Onset of seizures at 11 years of age or younger
b. Multiple seizures types( must include TS or TA), including countable motor seizures that result in drops. Countable motor seizure types eligible for inclusion are: GTC, TS, CS, AS, and FS with observable motor symptoms.
c. Abnormal Congnotive development
d. EEG supports the diagnosis
* Subject must have hd at least 8 drop seizures in the last 4 weeks prior to enrollment
* Receiving at least 1 and up to to 4 concomitant AEDs, VNS and Ketogenic diet permitted
* Subject's parent or a caregiver willing to maintain an electronic seizure diary
KEY EXCLUSION CRITERIA
* Subject has a known hypersensitivity to fenfluramine
* Seizure etiology is degenerative neurological disease
* History of hemiclonic seizures in the first year of life
* Cluster drop seizures can not be counted
* Caregiver is not reliable to maintain seizure diary
SELECTION CRITERIA FOR PART 1:
* All subjects must have satisfactorily completed Part 1 of the study in the opinion of the Investigator and the Sponsor.