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Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults

PHASE3RECRUITING

The primary objective is to evaluate the efficacy of carisbamate (YKP509) as adjunctive treatment in reducing the number of drop seizures (tonic, atonic, and tonic-clonic) compared with placebo in pediatric and adult subjects (age 4-55 years) diagnosed with Lennox Gastaut Syndrome (LGS).

Study details:

The secondary objectives are:. * To evaluate the efficacy of carisbamate (YKP509) as adjunctive treatment in reducing the total number of seizures compared with placebo in pediatric and adult subjects diagnosed with Lennox Gastaut Syndrome (LGS). * Evaluate the safety, tolerability of carisbamate in the LGS population.

* Evaluate steady-state pharmacokinetics of carisbamate in subjects with Lennox Gastaut.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  1. Subject must have a documented history of Lennox-Gastaut syndrome by: Evidence of more than one type of seizure, of which at least one should be an atonic or tonic seizure
  2. History of an electroencephalogram (EEG) reporting diagnostic criteria for LGS (abnormal background activity accompanied by slow, spike and wave pattern <3.0 Hz)
  3. History of developmental delay
  4. Male or female subjects
  5. Subjects must be age 4-55 years at the time of consent/assent
  6. Must have been <11 years old at the onset of LGS
  7. Subjects must have experienced at least 2 drop seizures with potential to fall (tonic, atonic, tonic-clonic) during the 4-week Baseline period preceding randomization (minimum of 4 drop seizures in the first two weeks and 4 in the last two weeks).
  8. Subjects must have been receiving 1 to 4 concomitant anti-seizure medications (ASMs) at a stable dose for at least 4 weeks before Visit 1
  9. If not taking Epidiolex, subjects may take other approved cannabidiol or over the counter cannabidiol products.
  10. Dietary therapy and any CNS stimulator settings must be stable for 4 weeks prior to baseline and maintain stable regimen throughout the study.
  11. Parents or caregivers must be able to keep accurate seizure diaries
  12. Subject is either not of childbearing potential, defined as premenarchal, postmenopausal for at least 1 year or surgically sterile.
  13. Subject and/or caregiver(s)/legal representative must be willing and able to give informed assent/consent for participation in the study
  14. Subject and their caregiver must be willing and able (in the investigator's opinion) to comply with all study requirements
  15. History of COVID-19 vaccination is permitted

Exclusion criteria

  1. Etiology of subject's seizures is a progressive neurologic disease. Subjects with tuberous sclerosis will not be excluded from study participation, unless there is a progressive brain tumor
  2. Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease, hepatic disease) that in the opinion of the investigator(s) could affect the subject's safety or study conduct
  3. Subjects who were on adrenocorticotropic hormone (ACTH) therapy in the 6 months prior to baseline
  4. Subject on dietary therapy for less than 4 weeks prior to screening visit (Visit 1) or suffers from frequent stooling
  5. Current use of felbamate with less than 18 months of continuous exposure
  6. Concomitant use of vigabatrin: subjects who took vigabatrin in the past must be discontinued for at least 5 months before Visit 1
  7. Subject who had a history of hypoxia which needed emergency resuscitation within 12 months prior to baseline
  8. Status epilepticus within 12 weeks prior to Visit 1
  9. Any clinically significant illness (including COVID-19) in the 4 weeks prior to Visit 1, as evaluated by the Investigator
  10. Subject has clinically significant abnormal laboratory values, in the investigator's opinion, at Visit 1 or time of randomization (Visit 2)
  11. Subject has a history of any serious drug-induced hypersensitivity, e.g., toxic epidermal necrolysis, or Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS] or any drug-related rash requiring hospitalization
  12. Vagus Nerve Stimulation (VNS), Deep Brain Stimulation (DBS), Responsive Neurostimulator System (RNS) or other neurostimulation for epilepsy device implanted or activated <5 months year prior to enrollment.
  13. Subject is pregnant, may be pregnant, lactating or planning to be pregnant
  14. Any suicidal ideation with intent, with or without a plan within 6 months before Visit 2
  15. Any suicidal behavior within 2 years before Visit 2
  16. Evidence of significant active hepatic disease.
  17. Subject with total bilirubin [TBL] >2 x ULN (except for Gilbert's syndrome).
  18. Active viral hepatitis (B or C) as demonstrated by positive serology at the Screening visit (Visit 1)
  19. History of positive antibody/antigen test for human immunodeficiency virus (HIV)
  20. If taking Epidiolex, subject may not use other approved cannabidiol or over the counter cannabidiol products
  21. Scheduled for epilepsy-related surgery, VNS insertion, or any other stimulators/surgery during the projected course of the study
  22. Subject who has taken or used any investigational drug or device in the 4 weeks prior to the screening visit (Visit 1)
  23. Concomitant use of medications known to be strong inducers of cytochrome P450 (CYP3A)
  24. Evidence of cardiac disease, including unstable angina, myocardial infarction, within the past 2 years
  25. Subject with a short QTc interval (<340 msec) or long QTc interval (>460 msec) as confirmed by a repeated electrocardiogram (ECG)
  26. Benzodiazepine rescue administered on average more than once a week in the month before Visit 1
  27. Previous exposure to carisbamate or sensitivity/allergy to components of the oral suspension.

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    PHASE3

trial

Study ID

NCT05219617

Intervention or treatment

DRUG: Carisbamate

Conditions

  • Seizures
  • Lennox Gastaut Syndrome

  • Condition: Seizures, Lennox Gastaut Syndrome

  • DRUG: Carisbamate

  • Heidelberg, Australia and more

  • Sponsor: SK Life Science, Inc.

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Are you running this trial?

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Research sites nearby

Closest Location:

Austin Hosptial

Select from list below to view details:

  • Austin Hosptial

    Heidelberg, Australia

  • Alfred Health

    Melbourne, Australia

  • Perth's Children Hospital

    Nedlands, Australia

  • Queensland Children's Hospital

    South Brisbane, Australia

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Who is running the clinical trial?

SLSI

SK Life Science, Inc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Carisbamate 200 mg BID arm
  • Age: 4 to \<12y\* Titration: 2 mg/kg BID Maintenance: 4 mg/kg BID
  • Age: ≥12 y Titration: 100 mg BID Maintenance: 200 mg BID
Drug: Carisbamate
    EXPERIMENTAL: Carisbamate 300 mg BID arm
    • Age: 4 to \<12y\* Titration: 2.75 mg/kg BID Maintenance: 5.5 mg/kg BID
    • Age: ≥12 y Titration: 150 mg BID Maintenance: 300 mg BID
    Drug: Carisbamate
      PLACEBO_COMPARATOR: Placebo matched to 200 mg BID arm
      • Age: 4 to \<12y\* Titration: Volume equivalent to 2 mg/kg BID Maintenance: Volume equivalent to 4 mg/kg BID
      • Age: ≥12 y Titration: Volume equivalent to 100 mg BID Maintenance: Volume equivalent to 200 mg BID
      Drug: Carisbamate
        PLACEBO_COMPARATOR: Placebo matched to 300 mg BID arm
        • Age: 4 to \<12y\* Titration: Volume equivalent to 2.75 mg/kg BID Maintenance: Volume equivalent to 5.5 mg/kg BID
        • Age: ≥12 y Titration: Volume equivalent to 150 mg BID Maintenance: Volume equivalent to 300 mg BID
        Drug: Carisbamate

          What is the study measuring?

          Primary Outcome

          MeasureDescriptionTime Frame
          Primary outcome will be the percentage change from baseline in the total frequency (average per 28 days) of countable drop seizures with potential to fall (tonic, atonic, tonic-clonic) seizures during the double-blind treatment period.Efficacy of Carisbamate YKP5093 years

          Secondary Outcome

          MeasureDescriptionTime Frame
          The percentage of subjects with at least a 50% reduction from baseline in the total frequency of drop seizures (tonic, atonic, tonic-clonic) during the double-blind treatment period.Efficacy of Carisbamate YKP5093 years
          Percentage change from baseline in the frequency of all types of seizures (total seizures) during the double-blind treatment period.Efficacy of Carisbamate YKP5093 years
          Subject/Caregiver Global Impression of Change (S/CGIC) in overall condition score at the last visit.Efficacy of Carisbamate YKP509- Scoring will be from 1 to 7 with 1 (very much improved) to 7 (very much worse)3 years
          Are you running this trial?If you're a clinic or sponsor, you can claim this study.
          Claim this trial

          References

          Clinical Trials Gov: Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults

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