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EPX-100 for Dravet Syndrome (ARGUS Trial)
Phase 2
Recruiting
Research Sponsored by Epygenix
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical diagnosis of Dravet Syndrome with specific seizure criteria
Sexually active women of child-bearing potential (WCBP) must be using a medically acceptable method of birth control and have a negative serum or urine pregnancy test at the screening (Visit 1) and Randomization (Visit 2)
Must not have
Seizures secondary to specific causes
Prior or concurrent use of lorcaserin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 weeks
Summary
This trial will test if EPX-100 is a safe and effective treatment for Dravet Syndrome.
Who is the study for?
This trial is for children and adults aged 2 years and older with Dravet Syndrome who experience frequent convulsive seizures. Participants must be able to maintain a seizure diary, use birth control if applicable, and have not been exposed to the study drug or similar drugs before. They should not have any significant medical conditions that could interfere with the trial.
What is being tested?
The study tests EPX-100 (Clemizole HCl) as an additional treatment alongside standard anti-epileptic drugs in patients with Dravet Syndrome. It aims to see if it's safe and effective at controlling seizures compared to a placebo (a substance with no active drug).
What are the potential side effects?
While specific side effects of EPX-100 are not listed here, common side effects may include allergic reactions, potential interactions with other medications, or exacerbation of existing health issues. The safety profile will be closely monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Dravet Syndrome and meet the specific seizure criteria.
Select...
I am using birth control and my pregnancy tests are negative.
Select...
I've had 4 or more seizures in the last 28 days.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My seizures are caused by a specific condition.
Select...
I have used lorcaserin before or am currently using it.
Select...
I am taking fenfluramine without an echocardiogram report.
Select...
I am not taking any medications that interfere with EPX-100.
Select...
I am allergic or sensitive to EPX-100 (clemizole HCl).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 20 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The mean percent change in countable convulsive seizure frequency (CCSF) in the Titration and Maintenance (T+M) periods relative to baseline.
Secondary study objectives
The change in the Sleep Disturbance Scale for Children (SDSC) between EPX-100 and placebo by visit
The difference between EPX-100 vs placebo in proportion of participants with >25% reduction in the mean CCSF in the T+M periods relative to baseline.
The difference between EPX-100 vs placebo in proportion of participants with >50% reduction in the mean CCSF in the T+M periods relative to baseline.
+9 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: EPX-100 (clemizole HCl)Experimental Treatment1 Intervention
Group II: Placebo armPlacebo Group1 Intervention
Color- and taste-matched placebo oral solution dosed to match the active arm.
Find a Location
Who is running the clinical trial?
Liberyx TherapeuticsUNKNOWN
Forest Hills LabIndustry Sponsor
2 Previous Clinical Trials
72 Total Patients Enrolled
Harmony Biosciences, LLCIndustry Sponsor
8 Previous Clinical Trials
1,918 Total Patients Enrolled
EpygenixLead Sponsor
2 Previous Clinical Trials
48 Total Patients Enrolled
George Nomikos, MD, PhDStudy DirectorHarmony Biosciences, LLC
Hahn-Jun Lee, M.Sc, Ph.D.Study DirectorEpygenix Therapeutics, Inc.
Lorianne Masouka, MDStudy DirectorEpygenix Therapeutics, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am using birth control and my pregnancy tests are negative.I am at least 2 years old.I have been diagnosed with Dravet Syndrome and meet the specific seizure criteria.I've been on the same epilepsy medication for over a month and am generally healthy.My seizures are caused by a specific condition.My participation has been approved after a review of my medical and seizure history.I have used lorcaserin before or am currently using it.I am taking fenfluramine without an echocardiogram report.I am not taking any medications that interfere with EPX-100.I've had 4 or more seizures in the last 28 days.I have a serious health condition.I haven't used any experimental drugs or devices in the last 3 months.I am allergic or sensitive to EPX-100 (clemizole HCl).You have thoughts of wanting to harm yourself or have tried to do so in the past.
Research Study Groups:
This trial has the following groups:- Group 1: EPX-100 (clemizole HCl)
- Group 2: Placebo arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.