Phase 3 Lennox-Gastaut Syndrome Trial Ends in Positive Results
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Phase 3 Lennox-Gastaut Syndrome Trial Ends in Positive Results

According to a story from gurufocus.com, the pharmaceutical company Zogenix, Inc., has recently announced top-line results from its phase 3 clinical trial. This trial is testing FINTEPLA® as a treatment for Lennox-Gastaut syndrome, a rare disorder that causes epileptic seizures in early childhood. The findings from the trial were positive with the drug satisfying the study’s primary endpoint and reducing the number of seizures.

About Lennox-Gastaut Syndrome (LGS)

Lennox-Gastaut syndrome is a rare and severe form of childhood epilepsy. The disease is most characterized by cognitive dysfunction and frequent seizures of varying types. The syndrome appears to have a variety of causes, such as certain genetic mutations, brain tumors, and congenital infections. It also may appear alongside genetic disorders such as tuberous sclerosis. With symptoms first appearing at around 3-5 years, most patients continue to face seizures for much of their lives. Tonic seizures are the most common. Other symptoms include status epilepticus, vision problems, and slow spike waves on electroencephalograms (EEG). Treatment may include a variety of medications, but Lennox-Gastaut syndrome rarely responds strongly to typical antiseizure drugs. Other approaches may include a ketogenic diet and certain surgical operations. The syndrome is considered responsible for around four percent of epilepsy cases in children. To learn more about Lennox-Gastaut syndrome, click here.

Trial Results

The phase 3 trial consisted of two parts. The first part was a placebo controlled double-blind study that evaluated FINTEPLA as a supplementary medication to patients’ current treatment plan. The second part is still ongoing at this juncture and consists of a year long open label extension study. A total of 263 patients with Lennox-Gastaut syndrome were included in the trial. Patients had tried an average of seven other medications before starting the study. In the trial, patients getting FINTEPLA saw their drop seizure (the severe and most dangerous type) frequency decrease by a median of 26.5 percent. 25.3 percent of these patients saw a reduction in seizures by at least 50 percent.

Ultimately, the findings highlight the potential of this drug to be an effective future treatment for this rare and dangerous form of epilepsy.