A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome
Saves the questions and what to expect into your notes, next to the visit they belong to.
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Lead
Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
Age
2–35
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or non-pregnant, non-lactating female, age 2 to 35 years, inclusive as of the day of the Screening Visit.
Clinical diagnosis of Lennox-Gastaut syndrome, where seizures that result in drops are not completely controlled by current antiepileptic treatments.
Onset of seizures at 11 years of age or younger.
Abnormal cognitive development.
Must be receiving at least 1 concomitant AED and up to 4 concomitant anti-epileptic treatments.
You may not be if
Etiology of seizures is a degenerative neurological disease.
History of hemiclonic seizures in the first year of life.
Subject only has drop seizures in clusters, where individual seizures cannot be counted reliably.
Pulmonary arterial hypertension.
Current or past history of cardiovascular or cerebrovascular disease, such as cardiac valvulopathy, myocardial infarction or stroke.
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.
Taking felbamate for less than 1 year prior to screening and/or does not have stable liver function and hematology laboratory tests, and/or the dose has not been stable for at least 60 days prior to the Screening Visit.
Currently receiving an investigational product.
Institutionalized in a general nursing home (ie, in a facility that does not specialize in epilepsy care).
A clinically significant condition, or has had clinically relevant symptoms or a clinically significant illness in the 4 weeks prior to the Screening Visit, other than epilepsy, that would negatively impact study participation, collection of study data, or pose a risk to the subject.
Clareo Health | A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome
