Evaluating clemizole HCl for treating Lennox-Gastaut syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, Phase 3, randomized, double-blind, placebo-controlled study aims to assess the efficacy and safety of clemizole HCl as an adjunctive therapy for patients with Lennox-Gastaut syndrome (LGS). Participants, including children and adults aged 2 to 55, will undergo an observational period followed by a double-blind phase where they will receive either clemizole HCl or a placebo. The study will also include an optional open-label extension period for those who complete the initial phases. The goal is to determine if clemizole HCl can effectively reduce seizure frequency and improve overall patient outcomes.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. Males or females, ages ≥2 to ≤55 years, at the time of Screening.
2. Participant/parent/legal authorized representative (LAR) willing and able to give written informed consent/assent.
3. 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 Exclusion Criteria:

1. Known sensitivity, allergy, or previous exposure to clemizole HCl.
2. 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).
3. Family history of sudden cardiac death, unexplained death, or death from a primary dysrhythmia potentially associated with QT prolongation in any family member.
4. 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 within the last 6 months requiring resuscitation, or progressive degenerative disease or any other condition, which in the opinion of the investigator, could affect seizure control.
5. Epilepsy surgery planned during the study or epilepsy surgery within 6 months prior to Screening.
6. Concomitant use of fenfluramine.
7. Prior or concomitant use of lorcaserin.

Where it's running

• University of Miami Miller School of Medicine
  Miami, Florida, United States Recruiting
• AdventHealth Innovation Tower
  Orlando, Florida, United States Recruiting
• Re:Cognition Health
  Chicago, Illinois, United States Recruiting
• Norton Children's Medical Center
  Louisville, Kentucky, United States Recruiting
• Minnesota Epilepsy Group, P.A.
  Roseville, Minnesota, United States Recruiting
• Children's Nebraska
  Omaha, Nebraska, United States Recruiting

+21 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Juby Philip
• Email: clinicaltrials@harmonybiosciences.com
• Phone: (302) 559-4320

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Comparing surgery and medications for treating Lennox-Gastaut syndrome

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• Evaluating Carisbamate for Seizures in Lennox Gastaut Syndrome

  This study is testing if a new medication called carisbamate can help reduce drop seizures in people aged 4 to 55 with Lennox Gastaut Syndrome.

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• Adaptive deep brain stimulation for children with Lennox–Gastaut syndrome

  This trial will test adaptive deep brain stimulation using the Picostim device to try to reduce seizures in children aged 5–14 with Lennox–Gastaut syndrome.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.