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Tests treatment safety and results for Lennox Gastaut Syndrome
Official title An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome
ClinicalTrials.gov ID: NCT05066217
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 lennox gastaut 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 HCL (EPX-100) as adjunctive therapy in children and adult participants with Lennox-Gastaut syndrome (LGS).
- 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 to 55
You may be able to join if
- Males or females, ages ≥2 to ≤55 years, at the time of Screening.
- Participant/parent/legal authorized representative (LAR) willing and able to give written informed consent/assent.
- Diagnosis of LGS, including:
- Evidence of at least one type of countable major motor seizure.
- History of electroencephalogram (EEG) consistent with LGS (abnormal background activity, and one of the following: 1) slow spike-wave discharges...
You likely can't join if
- Known sensitivity, allergy, or previous exposure to clemizole HCl.
- Known history of long QT syndrome or any significant history of a serious abnormality of the electrocardiogram (ECG) (e.g., recent myocardial...
- Family history of sudden cardiac death, unexplained death, or death from a primary dysrhythmia potentially associated with QT prolongation in any...
- Seizures secondary to illicit drug or alcohol use, infection, neoplasm, demyelinating disease, degenerative neurological disease, or progressive...
- Epilepsy surgery planned during the study or epilepsy surgery within 6 months prior to Screening.
- Concomitant use of fenfluramine.
See the full eligibility criteria
- Males or females, ages ≥2 to ≤55 years, at the time of Screening.
- Participant/parent/legal authorized representative (LAR) willing and able to give written informed consent/assent.
- Diagnosis of LGS, including:
- Evidence of at least one type of countable major motor seizure.
- History of electroencephalogram (EEG) consistent with LGS (abnormal background activity, and one of the following: 1) slow spike-wave discharges [\<2.5 Hz], or 2) paroxysmal fast activity during sleep).
- Abnormal cognitive development.
- Onset of seizures at 11 years of age or younger. Key
- Known sensitivity, allergy, or previous exposure to clemizole HCl.
- Known history of long QT syndrome or any significant history of a serious abnormality of the electrocardiogram (ECG) (e.g., recent myocardial infarction, clinically significant arrhythmia).
- Family history of sudden cardiac death, unexplained death, or death from a primary dysrhythmia potentially associated with QT prolongation in any family member.
- Seizures secondary to illicit drug or alcohol use, infection, neoplasm, demyelinating disease, degenerative neurological disease, or progressive central nervous system disease, metabolic illness, recent anoxic episode...
- Epilepsy surgery planned during the study or epilepsy surgery within 6 months prior to Screening.
- Concomitant use of fenfluramine.
- Prior or concomitant use of lorcaserin.
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Orange, California, United States
- Wilmington, Delaware, United States
- Kissimmee, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Winter Park, Florida, United States
- Chicago, Illinois, United States
- Louisville, Kentucky, United States
- Detroit, Michigan, United States
- Roseville, Minnesota, United States
- Omaha, Nebraska, United States
- Marlboro, New Jersey, United States
- New York, New York, United States
- Charlotte, North Carolina, United States
- Durham, North Carolina, United States
- Morrisville, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
+ 2 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 to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Orange, California, United States; Wilmington, Delaware, United States; Kissimmee, Florida, United States; Miami, Florida, United States; Orlando, Florida, United States and 16 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.