Lennox-Gastaut syndrome
Conditions
Interventions
ZX008 (Fenfluramine Hydrochloride) Oral Solution
0.2 - 0.8 mg/kg. max 30mg/day
Sponsors
YAMAMOTO Hideichiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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.
Exclusion criteria
Exclusion criteria: -Etiology of seizures is a degenerative neurological disease. -A 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in frequency of seizures that result in drops between baseline and the combined Titration and Maintenance Periods (T+M) | — |
Countries
Australia, Belgium, Canda, Denmark, France, Germany, Italy, Japan, Mexico, Netherland, Poland, Spain, Sweeden, US
Contacts
Public ContactHideichiro YAMAMOTO
Syneos Health Clinical K.K.
Outcome results
None listed