A study of an investigational drug called ZX008 in patients who have refractory Lennox-Gastaut syndrome has produced promising results, according to Zogenix. For more detailed information, you can view the source press release here, at Globe Newswire.
About Lennox-Gastaut Syndrome
Lennox-Gastaut syndrome (LGS) is a severe form of epilepsy that develops during childhood, and often between the ages of two and five. People who are affected by LGS typically suffer from multiple seizures per day, and have intellectual disability. LGS is associated with multiple types of seizure, including tonic seizures (uncontrollable muscle contraction), atypical absence seizures (loss of consciousness), and drop attacks (weak muscle tone that can cause falls and serious injury).
According to the source press release, between thirty to fifty thousand people in the US and Europe are thought to be affected by LGS.
About the Study
Results from a Phase 2 clinical trial of ZX008 (low-dose fenfluramine hydrochloride) in patients with refractory LGS were shared in the journal Epilepsia. The study found that the drug was well-tolerated, and associated with reduced seizures in most patients.
The open-label and dose-finding study took place over twenty weeks, with an additional long-term extension for patients that responded in the first phase. Thirteen patients with refractory LGS took part in this trial, and, on average, they had previously failed five treatments for epilepsy.
The 20-week phase of the study found that approximately two thirds (62%) of the patients that took part achieved a 50% or more reduction in their convulsive seizure frequency. Furthermore, about one quarter (23%) had 75% or more reduction.
Following 15 months of the long-term extension study, which nine patients took part in, patients achieved a median reduction in convulsive seizure frequency of 58% compared to their baseline frequencies. One third of patients achieved a reduction of 75% or more.
A spokesperson for Zogenix said that the results are “compelling”, and support a pivotal Phase 3 trial of ZX008 for LGS.
For a more detailed breakdown of the results, you can view the original press release here.