Dravet syndrome
Conditions
Interventions
ZX008 (Fenfluramine Hydrochloride) Oral Solution
Initial dose: 0.2mg/kg, Max daily dose: 30mg
Sponsors
YAMAMOTO Hideichiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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).
Exclusion criteria
Exclusion criteria: - Current or past history of cardiovascular or cerebrovascular disease, myocardial infarction or stroke. - 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. - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Long-term safety and tolerability as measured by treatment emergent adverse events, including clinical labs, vital signs, and examination findings. | — |
Countries
Australia, Belgium, Canda, Denmark, France, Germany, Italy, Japan, Korea, Netherland, Norway, Spain, Sweeded, UK, US
Contacts
Public ContactHideichiro YAMAMOTO
Syneos Health Clinical K.K.
Outcome results
None listed