Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
Age
2–18
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or non-pregnant, non-lactating female, age 2 to 18 years, inclusive as of the day of the Screening Visit.
Clinical diagnosis of Dravet syndrome, where convulsive seizures are not completely controlled by current antiepileptic drugs.
Must have a minimum # of convulsive seizures per 4-week period for past 12 weeks prior to screening.
All medications or interventions for epilepsy must be stable for at least 4 weeks prior to screening and expected to remain stable throughout the study.
No cardiovascular or cardiopulmonary abnormality based on ECHO, ECG or physical examination.
Parent/caregiver is willing and able to be compliant with diary completion, visit schedule and study drug accountability.
You may not be if
Pulmonary arterial hypertension.
Current or past history of cardiovascular or cerebrovascular disease, such as cardiac valvulopathy, myocardial infarction or stroke.
Current or past history of glaucoma.
Moderate or severe hepatic impairment.
Receiving concomitant therapy with: anorectic agents; monoamine-oxidase inhibitors; medications that act via serotonin including serotonin reuptake inhibitors; atomoxetine, or other centrally-acting noradrenergic agonist; or cyproheptadine.
Currently receiving or has received stiripentol in the past 21 days prior to Screening.
Currently taking carbamazepine, oxcarbamazepine, eslicarbazepine, phenobarbital, or phenytoin, or has taken any of these within the past 30 days.
Positive result on tetrahydrocannabinol (THC) or cannabidiol (CBD) test at the Screening Visit.
A clinically significant medical condition,that would interfere with study participation, collection of study data, or pose a risk to the subject.
Clareo Health | A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) in Children and Young Adults With Dravet Syndrome
