Zogenix Announces Initiation of Multi-National Phase 3 Clinical Trial for ZX008 in Dravet Syndrome
“We are excited to begin this clinical trial, as we view ZX008 as an important potential new treatment option for children and adolescents with Dravet syndrome,” said
The Phase 3 program for ZX008 includes two randomized, double-blind placebo-controlled studies investigating two dose levels of ZX008 (0.2 mg/kg/day and 0.8 mg/kg/day, up to a maximum daily dose of 30 mg), as well as placebo.
“The initiation of Study 1502, which will take place at sites in
About Dravet Syndrome
Dravet syndrome (also known as Severe Myoclonic Epilepsy of Infancy) is a rare, severe and therapy-resistant form of epilepsy most often caused by an identifiable gene defect that results in abnormal functioning of a sodium channel in the brain. Children with Dravet syndrome experience severe, long-lasting, fever-related seizures in the first year of life. Other seizures typically arise later, including myoclonus (involuntary muscle spasms) and status epilepticus (prolonged seizures), which often result in severe cognitive and developmental impairment. Episodes of status epilepticus require immediate emergency care and can be fatal.
Individuals with Dravet syndrome face a higher incidence of SUDEP (sudden unexplained death in epilepsy) and have associated conditions, which also require proper treatment and management. Children with Dravet syndrome do not outgrow this condition and it affects every aspect of their daily lives.
Forward Looking Statements
Andrew McDonaldFounding Partner, LifeSci Advisors LLC646-597-6987 | Andrew@lifesciadvisors.com