This is an international, multicenter, open-label, long-term safety study of ZX008 in pediatric and young adult subjects with Dravet syndrome who have successfully completed 14 weeks of treatment in the core study (ZX008-1501 and ZX008-1502).
An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride HCl) Oral Solution as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome
This is an international, multicenter, open-label, long-term safety study of ZX008 in pediatric and young adult subjects with Dravet syndrome who have successfully completed 14 weeks of treatment in one of the core studies (ZX008-1501 and ZX008-1502) and are candidates for continuous treatment for an extended period of time. Subjects will be permitted to participate in the present study after they complete the final evaluation at Day 113 in one of the core studies. This trial will consist of a 12-month Open-Label Extension (OLE) Treatment Period and a 2-week Post-Dosing Period. Thus, subjects who complete this trial will have been treated with ZX0008 for a minimum of up to 1 year (including their participation in both the core study and this study).
Male or non-pregnant, non-lactating female, age 2 to 18 years, inclusive as of the day of the core study Screening Visit.
Satisfactory completion of the core study in the opinion of the investigator and the sponsor.
A documented medical history to support a clinical diagnosis of Dravet syndrome,where convulsive seizures are not completely controlled by current antiepileptic drugs.
Parent/caregiver is willing and able to be compliant with diary completion, visit schedule and study drug accountability.
Subject's parent/caregiver has been compliant with diary completion during the core study, in the opinion of the investigator (eg, at least 90% compliant).
Key Exclusion Criteria:
Current or past history of cardiovascular or cerebrovascular disease, myocardial infarction or stroke.
Current cardiac valvulopathy or pulmonary hypertension that the investigator, parent,IPCAB, IDSMC, or sponsor deems clinically significant and warrants discontinuation of study medication.
Current or past history of glaucoma.
Moderate or severe hepatic impairment.
Receiving concomitant therapy with: centrally-acting anorectic agents;monoamineoxidase inhibitors; any centrally-acting compound with clinically appreciable amount of serotonin agonist or antagonist properties, including serotonin reuptake inhibition; atomoxetine, or other centrally-acting noradrenergic agonist;cyproheptadine, and/or cytochrome P450 (CYP) 2D6/3A4/2B6 inhibitors/substrates.
Currently taking carbamazepine, oxcarbamazepine, eslicarbazepine, phenobarbital, or phenytoin, or has taken any of these within the past 30 days, as maintenance therapy.
Currently receiving or has received stiripentol in the past 21 days prior to Visit 1.
Unwilling to refrain from large or daily servings of grapefruits and/or Seville oranges, and their juices beginning with the Visit 1 and throughout the study.
A clinically significant condition, or has had clinically relevant symptoms or a clinically significant illness at Visit 1, other than epilepsy, that would negatively impact study participation, collection of study data, or pose a risk to the subject.
University of California San Francisco San Francisco, California, 94143, USA
Sutter Health - Sacramento Sacramento, California, 95746, USA
Collaborative Neuroscience Network Long Beach, California, 90806, USA
Children's Hospital Los Angeles Los Angeles, California, 90027, USA
Rady Children's Hospital San Diego San Diego, California, 92123, USA
accepting new patients by invitation only
Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.