Lennox Gastaut Syndrome study: Clemizole HCl
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 (EPX-100)?
An investigational oral solution being studied as an adjunctive therapy for Lennox‑Gastaut syndrome.
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
- The study will see if clemizole HCl can reduce seizures and is safe when used with other medicines for Lennox‑Gastaut syndrome.
- Who it's for
- Participants must have Lennox‑Gastaut syndrome and be children or adults who are already taking other seizure medicines.
- What's involved
- You will receive either clemizole HCl or a placebo, and will have regular clinic visits and seizure‑tracking tests to monitor effectiveness and safety.
- Time commitment
- The study lasts several months, with multiple scheduled visits to give medication and complete assessments.
- 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.
- 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...
- Abnormal cognitive development.
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.
- 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 is enrolling
- Miami, Florida, United States
- Orlando, Florida, United States
- Chicago, Illinois, United States
- Louisville, Kentucky, 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
- Dallas, Texas, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Changsha, Hunan, China
- Shanghai, Shanghai Municipality, China
- Beijing, China
- Changchun, China
- Changsha, China
+ 36 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, but 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?
This study is enrolling now at Miami, Florida, United States; Orlando, Florida, United States; Chicago, Illinois, United States; Louisville, Kentucky, United States; Roseville, Minnesota, United States; Omaha, Nebraska, United States and 50 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.