EPX-100 for Dravet Syndrome (ARGUS Trial)

"EPX-100 (Clemizole HCl) is being investigated in 2 concurrent clinical trials, neither of which have reached Phase 3. Clemizole HCI research is primarily based out of Cincinnati, Ohio, but there are 16 total locations running studies on the drug."

"The clinical trial is still recruiting patients, as stated on the website clinicaltrials.gov. The study was originally posted on September 15th 2020 and has been updated as recently as October 31st 2020."

"Currently, there are 16 hospitals recruiting patients for this clinical trial. These locations include The Hospital for Sick Children in Toronto, Seattle Children's in Seattle and Children's and Women's Health Centre of British Columbia in Vancouver. There are also other recruitment centres spread across North America."

"One hundred eligible patients are required to carry out this study. The sponsor, Epygenix, will be administering the trial from several locations; two examples include The Hospital for Sick Children in Toronto, Canada and Seattle Children's in Seattle, USA."

"Our team at Power estimates that EPX-100 (Clemizole HCl) is a safe drug, but there is no data supporting its efficacy. This makes it a Phase 2 drug on our scale."

"Over the course of 4 weeks, this study will aim to evaluate the mean percent change in countable convulsive seizure frequency (CCSF1) in patients receiving EPX-100 compared to those receiving a placebo. Secondary outcomes being measured include the difference in number of countable convulsive seizure-free days between the two groups during the Titration and Maintenance periods, as well as the number of convulsive seizure-free days and episodes of status epilepticus during the final 4-week Maintenance Phase."

"This trial is looking for 100 patients with syndrome that are 2-80 years old. To be eligible, patients should meet the following criteria: • A history of seizures that are generalized, unilateral clonic, and/or hemiclonic• Genetic mutation of the SCN1A gene must be documented.• Male and female participants 2 years and older at time of consent.• Participant or parent/Legally Authorized Representative (LAR) willing and able to provide written informed consent, assent (if applicable) prior to initiation of any study related procedures.• Onset of seizures prior"

"In order to take part in this trial, patients must between the ages of 2 and 80. Out of 1,328 similar clinical trials, this one is unique in that it only includes 391 for patients under 18 and 1037 for those over 65."

"EPX-100 (Clemizole HCl) is an effective medication for treating influenza, fever, and airway secretion clearance therapy."

"EPX-100 (Clemizole HCl), a drug that was first researched in 2020, received Phase 2 approval after its initial clinical trial. There are now 14 active research sites for EPX-100 (Clemizole HCl) located in 2 countries."