A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome

Launched by EPYGENIX · Jul 6, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a medication called EPX-100, also known as clemizole hydrochloride, to see how safe and effective it is for people with Dravet syndrome, a severe form of epilepsy. The trial aims to help those whose seizures are not fully controlled by their current treatments. If you're interested in participating, you need to be at least 2 years old and have a confirmed diagnosis of Dravet syndrome, with a history of seizures starting before 18 months of age. You must also be willing to keep a detailed diary of your seizures and medications throughout the study.

Participants in this trial can expect to be closely monitored by healthcare professionals. This includes a review of your health history, seizure records, and brain scans. You'll need to be on stable anti-seizure medications for at least 30 days before joining. While the trial is open to all genders, certain health conditions or medications may disqualify you from participating, so it's important to discuss your medical history with the study team. Overall, this research could lead to new treatment options for those struggling with Dravet syndrome.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. Male and female participants 2 years and older at time of consent.
• • 2. 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.
• 3. Clinical diagnosis of Dravet syndrome. Participants must have seizures which are not completely controlled by AEDs with the following criteria:
• • Onset of seizures prior to 18 months of age,
• • Normal development at onset,
• • History of at least one type of countable motor seizure (CMS),
• • Brain MRI without cortical malformation (not including mild atrophy associated with the natural progression of Dravet syndrome),
• • Genetic mutation of the SCN1A gene must be documented.
• Key Exclusion Criteria:
• • 1. Known sensitivity, allergy, or previous exposure to clemizole HCl.
• • 2. Exposure to any investigational drug or device \<90 days prior to screening or plans to participate in another drug or device trial at any time during the study.
• • 3. Seizures secondary to illicit drug (this includes concomitant use of tetrahydrocannabinol \[THC\] and nonprescription cannabidiol preparations) or alcohol use, infection, neoplasm, demyelinating disease, degenerative neurological disease, or central nervous system (CNS) disease deemed progressive, metabolic illness, or progressive degenerative disease.
• • 4. Prior or concurrent use of lorcaserin.
• • 5. Concurrent use of fenfluramine.
• • 6. Epilepsy surgery planned during the study or epilepsy surgery within 6 months prior to Screening.