In a Phase II, multicenter, randomized, double-blind, placebo-controlled study, Epygenix will test the investigational drug, EPX-100 (Clemizole Hydrochloride, oral solution), as an adjunctive therapy for children with Dravet syndrome (2-17 years old) who suffer from uncontrolled seizures. The trial will take place at investigational sites in the US.
The study goal is to compare EPX-100 efficacy versus placebo (measured by percent change in seizure frequency).
To participate, your child would need to meet eligibility criteria. At a minimum, these criteria include:
- Clinical and genetic diagnosis of Dravet syndrome
- Seizures not adequately controlled by current anti-epileptic drugs
- Experience 4 or more convulsive seizures during a 4-week baseline period
Your child’s personal data will remain private and confidential. Any medical data collected in the study will be used exclusively for therapy development. The aim is to develop transformative therapies to improve the lives of patients and families living with Dravet syndrome.
Trial site locations and contact information are listed here, and more information on the trial and trial locations can also be found on Clinicaltrials.gov NCT04462770
You can watch an informational webinar by Epygenix for DSF here and slides from the presentation can be downloaded here.