Zogenix has just announced that they have not only finished enrollment in their Phase 3 investigation of Fintepla for Lennox-Gastaut Syndrome (LGS), but that the final patient has been randomized and begun their treatment. This therapy is being investigated as a treatment for the seizures that accompany a LGS diagnosis.

LGS is a severe and rare type of epilepsy. Its onset occurs in childhood and it is typically treatment resistant.

Fintepla has orphan drug designation by both the EMA and the FDA for LGS.

This Phase 3 study is called 1601. It was initiated following “compelling data” received in the company’s Phase 2 investigation. Zogenix strongly believes that Fintepla has the ability to become a new therapeutic option for LGS patients, aiding in the control of the seizures they experience.

About the Study

This multinational study has enrolled 263 LGS patients. All patients were randomized into three different groups, each with around 87 patients. It is a placebo-controlled, double-blind study investigating the effect of two different fixed doses of the drug Fintepla. Both adults and children are enrolled.

For the first 4 weeks of the investigation, the researchers worked to establish a baseline of how frequent the patient’s seizures were. After this baseline was established, the researchers randomized the patients. The participants will receive .2 mg/kg/day of Fintepla, .8 mg/kg/day of Fintepla, or placebo. At maximum, patients will receive 30 mg of the therapy each day. For two weeks there will be a dose titration. Then, the patients will be given a fixed dose of the therapy for 12 more weeks.

This investigation’s primary endpoint is change in the amount of drop seizures from baseline to treatment period at the .8 mg/kg/day dose of Fintepla in comparison to placebo.

Secondary endpoints in this study are the change in the amount of drop seizures from baseline to treatment period at the .2 mg/kg/day dose of Fintepla in comparison to placebo, as well as the proportion of participants who experience 50% fewer drop seizures.

Researchers expect to have safety and efficacy results from this trial by the 1st quarter of next year.

There is an open-label extension available for participants who finish the treatment period. The open-label study will last 12 months and will work to investigate the safety, effectiveness, and tolerability of the therapy long-term.

You can read more about this Phase 3 investigation for LGS and it’s progress here.