Eisai has announced that they will begin a Phase 3 trial, titled MOMENTUM, to evaluate lorcaserin as a treatment for Dravet syndrome. This decision comes after a consultation with the FDA. In addition, they will conduct the MOMENTUM 2 trial as an expanded access program.
About Dravet Syndrome
Dravet syndrome is a rare dysfunction of the brain that results in seizures. These seizures typically begin in the first year of life and are accompanied by symptoms like cognitive impairment, motor deficits, and behavioral issues. As these seizures begin very early in life, it is often possible to obtain an early diagnosis. Doctors will then try to find the correct seizure medication for the individual in order to prevent future seizures and reduce their severity. If treatment is started early enough, it could also improve cognitive function.
About the Studies
The MOMENTUM 1 trial will be randomized, multicenter, double-blind, and placebo controlled. Researchers plan to enroll up to 58 participants across 20 sites in the US. They hope to meet the primary endpoint of superior percent change in frequency of seizures in comparison to the placebo. Secondary endpoints include a 50% responder rate, freedom from convulsive seizures, pharmacokinetics, safety, and tolerability.
The MOMENTUM 2 study is an extended access program that will treat Dravet syndrome patients, as well as those with other refractory epilepsies. A chart review, pharmacokinetics sub-study, and information on safety and seizure frequency will all be conducted throughout the course of the study. Dosing will be flexible.
Hopefully these studies provide positive results, as Dravet syndrome patients would be greatly benefited by another treatment option. Read more about the studies here.