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New treatment option for Dravet Syndrome
Official title A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome
ClinicalTrials.gov ID: NCT04462770
What this study is testing
What is Clemizole HCl?
Clemizole HCl is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for dravet syndrome.
Also referred to as EPX-100.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multicenter, Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole hydrochloride (EPX-100) as adjunctive therapy in children and adult participants with Dravet syndrome (DS).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 and older
You may be able to join if
- 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 and assent (if applicable) prior...
- Clinical diagnosis of DS. 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,
You likely can't join if
- Known sensitivity, allergy, or previous exposure to clemizole HCl.
- 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...
- Seizures secondary to illicit drug (this includes concomitant use of tetrahydrocannabinol [THC] and nonprescription cannabidiol preparations) or...
- Concurrent use of lorcaserin. Note: Prior use of lorcaserin is permitted if at least 30 days have passed since the last dose.
- Concurrent use of fenfluramine.
- Epilepsy surgery planned during the study or epilepsy surgery within 6 months prior to Screening.
See the full eligibility criteria
- 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 and assent (if applicable) prior to initiation of any study related procedures.
- Clinical diagnosis of DS. 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 DS),
- Genetic mutation of the SCN1A gene must be documented. Key
- Known sensitivity, allergy, or previous exposure to clemizole HCl.
- 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.
- Seizures secondary to illicit drug (this includes concomitant use of tetrahydrocannabinol [THC] and nonprescription cannabidiol preparations) or alcohol use, infection, neoplasm, demyelinating disease, degenerative...
- Concurrent use of lorcaserin. Note: Prior use of lorcaserin is permitted if at least 30 days have passed since the last dose.
- Concurrent use of fenfluramine.
- Epilepsy surgery planned during the study or epilepsy surgery within 6 months prior to Screening.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Little Rock, Arkansas, United States
- Los Angeles, California, United States
- Orange, California, United States
- San Francisco, California, United States
- New Haven, Connecticut, United States
- Wilmington, Delaware, United States
- Kissimmee, Florida, United States
- Winter Park, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Louisville, Kentucky, United States
- Ann Arbor, Michigan, United States
- Omaha, Nebraska, United States
- Hackensack, New Jersey, United States
- Marlboro, New Jersey, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Morrisville, North Carolina, United States
- Winston-Salem, North Carolina, United States
+ 34 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Little Rock, Arkansas, United States; Los Angeles, California, United States; Orange, California, United States; San Francisco, California, United States; New Haven, Connecticut, United States and 48 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.