Lennox-Gastaut syndrome (LGS) is a form of epilepsy. Most patients with this condition are resistant to current treatments and experience seizures throughout the duration of their life. They may face injuries from falls, cognitive impairment, and overall a reduced quality of life.
However, a new phase 3 trial which produced positive results may bring a new treatment option to this population of patients.
Phase 3 Trial
This Phase 3 trial was conducted by Zogenix to examine Fintepla in LGS. This was a two part global investigation.
Part 1
The first part of this trial was a placebo controlled evaluation of the safety, efficacy, and overall tolerability of the drug in combination with the participants’ current treatments.
This part of the study included 263 LGS patients who were experiencing uncontrolled seizures. All participants were between 2 and 35 years of age. Patients were divided into three groups. Two different dosages of the drug were studied, with the remaining patients receiving placebo.
Part 2
The second part of this study is an open-label extension study. This part of the study will last one year and will help to determine the effects of this therapy long-term.
Results
This trial did meet the primary endpoint of a reduction of seizure frequency. This effect was only statistically significant for the group of patients receiving the high dose of Fintepla.
Additionally, the therapy was found to be well-tolerated. These results are consistent with previous findings in Dravet syndrome.
From these results, researchers are hopeful it could become a new option for LGS patients.
More About Fintepla
Fintepla has already received Orphan Drug Designation by both the FDA and European Commission for LGS.
It is also currently under Priority Review for Dravet Syndrome by the FDA and the European Medicines Agency (EMA). For the FDA, results should be announced by March 25th of this year. Both of these applications are supported by two Phase 3 trials as well as an extension study which is still ongoing.
You can read more about this new investigative therapy for LGS here.
