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Tests treatment safety and results for Seizures
Official title Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
ClinicalTrials.gov ID: NCT05219617
What this study is testing
What is Carisbamate?
Carisbamate is an investigational medicine, being studied as a potential treatment for seizures.
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 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).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 to 55
You may be able to join if
- 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
- History of an electroencephalogram (EEG) reporting diagnostic criteria for LGS (abnormal background activity accompanied by slow, spike and wave...
- History of developmental delay
- Male or female people
You likely can't join if
- Etiology of subject's seizures is a progressive neurologic disease. people with tuberous sclerosis will not be excluded from study participation...
- Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease, hepatic disease) that in the opinion of the...
- people who were on adrenocorticotropic hormone (ACTH) therapy in the 6 months prior to baseline
- Subject on dietary therapy for less than 4 weeks prior to screening visit (Visit 1) or suffers from frequent stooling
- Current use of felbamate with less than 18 months of continuous exposure
- Concomitant use of vigabatrin: people who took vigabatrin in the past must be discontinued for at least 5 months before Visit 1 and must have...
See the full eligibility criteria
Who can join
- 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
- History of an electroencephalogram (EEG) reporting diagnostic criteria for LGS (abnormal background activity accompanied by slow, spike and wave pattern \<3.0 Hz)
- History of developmental delay
- Male or female people
- people must be age 4-55 years at the time of consent/assent
- Must have been \<11 years old at the onset of LGS
- people 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...
- people must have been receiving 1 to 4 concomitant anti-seizure medications (ASMs) at a stable dose for at least 4 weeks before Visit 1
- If not taking Epidiolex, people may take other approved cannabidiol or over the counter cannabidiol products. If taking cannabidiol other than Epidiolex, consult Medical Monitor to determine if it counts as a...
- Dietary therapy and any CNS stimulator settings must be stable for 4 weeks prior to baseline and maintain stable regimen throughout the study. The dietary therapy and CNS stimulators are not counted as an ASM.
- Parents or caregivers must be able to keep accurate seizure diaries
- Subject is either not of childbearing potential, defined as premenarchal, postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), if of childbearing...
- Subject and/or caregiver(s)/legal representative must be willing and able to give informed assent/consent for participation in the study
- Subject and their caregiver must be willing and able (in the investigator's opinion) to comply with all study requirements
- History of COVID-19 vaccination is permitted
What rules you out
- Etiology of subject's seizures is a progressive neurologic disease. people with tuberous sclerosis will not be excluded from study participation, unless there is a progressive brain tumor
- 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
- people who were on adrenocorticotropic hormone (ACTH) therapy in the 6 months prior to baseline
- Subject on dietary therapy for less than 4 weeks prior to screening visit (Visit 1) or suffers from frequent stooling
- Current use of felbamate with less than 18 months of continuous exposure
- Concomitant use of vigabatrin: people who took vigabatrin in the past must be discontinued for at least 5 months before Visit 1 and must have documentation showing no evidence of a vigabatrin-associated clinically...
- Subject who had a history of hypoxia which needed emergency resuscitation within 12 months prior to baseline
- Status epilepticus within 12 weeks prior to Visit 1
- Any clinically significant illness (including COVID-19) in the 4 weeks prior to Visit 1, as evaluated by the Investigator
- Subject has clinically significant abnormal laboratory values, in the investigator's opinion, at Visit 1 or time of randomization (Visit 2)
- 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
- 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. Stimulation...
- Subject is pregnant, may be pregnant, lactating or planning to be pregnant
- Any suicidal ideation with intent, with or without a plan within 6 months before Visit 2 (i.e., answering "Yes" to questions 4 or 5 in the Suicidal Ideation section of the age- specific Columbia-Suicide Severity Rating...
- Any suicidal behavior within 2 years before Visit 2 (i.e., answering YES to any question in the Suicidal behavior section of the age-specific Columbia-Suicide Severity Rating Scale (C-SSRS) in people aged 6 and above...
- Evidence of significant active hepatic disease. Stable elevations of liver enzymes (alanine aminotransferase (ALT), and aspartate aminotransferase (AST)) due to concomitant medication(s) will be allowed if they are \<3...
- Subject with total bilirubin [TBL] \>2 x ULN (except for Gilbert's syndrome).
- Active viral hepatitis (B or C) as demonstrated by positive serology at the Screening visit (Visit 1)
- History of positive antibody/antigen test for human immunodeficiency virus (HIV)
- If taking Epidiolex, subject may not use other approved cannabidiol or over the counter cannabidiol products
- Scheduled for epilepsy-related surgery, VNS insertion, or any other stimulators/surgery during the projected course of the study
- Subject who has taken or used any investigational drug or device in the 4 weeks prior to the screening visit (Visit 1)
- Concomitant use of medications known to be strong inducers of cytochrome P450 (CYP3A) including, but not limited to: phenobarbital, phenytoin, carbamazepine, primidone, rifampin, troglitazone, St. John's Wort...
- Evidence of cardiac disease, including unstable angina, myocardial infarction, within the past 2 years, uncontrolled heart failure, major arrhythmias, congenital short QT syndrome
- Subject with a short QTc interval (\ 460 msec) as confirmed by a repeated electrocardiogram (ECG)
- Benzodiazepine rescue administered on average more than once a week in the month before Visit 1
- Previous exposure to carisbamate or sensitivity/allergy to components of the oral suspension.
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
- Jacksonville, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Wellington, Florida, United States
- Boise, Idaho, United States
- Lexington, Kentucky, United States
- New Orleans, Louisiana, United States
- Baltimore, Maryland, United States
- Bethesda, Maryland, United States
- Rochester, Minnesota, United States
- Columbia, Missouri, United States
- Hackensack, New Jersey, United States
- New Brunswick, New Jersey, United States
- The Bronx, New York, United States
- Durham, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Austin, Texas, United States
- Dallas, Texas, United States
+ 43 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, 4 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States; Jacksonville, Florida, United States; Orlando, Florida, United States; Tampa, Florida, United States; Wellington, Florida, United States; Boise, Idaho, United States and 57 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.