Carisbamate in Adult & Pediatric Subjects With Lennox-Gastaut Syndrome (NCT03731715) | Clinical Trial Compass
CompletedPhase 1
Carisbamate in Adult & Pediatric Subjects With Lennox-Gastaut Syndrome
United States18 participantsStarted 2019-02-07
Plain-language summary
This is an open-label, multi-center study of carisbamate in adult and pediatric subjects with LGS, with single- and multiple-dose PK assessments from Days 1 through 73. There will be a Screening Period of up to 28 days and a Treatment Period of 87 days.
Who can participate
Age range
2 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Diagnosis of LGS as evidenced by the following:
. More than 1 type of generalized seizure, including drop seizures (atonic, tonic, or myoclonic), for ≥6 months before Visit 1
. Previous electroencephalogram reporting diagnostic criteria for LGS (abnormal background activity accompanied by slow spike-and-wave pattern \<2.5 Hz)
. Male or female aged ≥2 years at the time of consent
. Aged \<11 years at the onset of LGS
. Written informed consent signed by the subject or legal guardian prior to entering the study in accordance with the ICH GCP guidelines. Age appropriate assent will be obtained for children and adolescents. If the written informed consent is provided by the legal guardian because the subject is unable to do so, a written or verbal assent from the subject must also be obtained.
. Receiving 1 to 3 concomitant AEDs at a stable dose for ≥30 days before Visit 1 (vagal nerve stimulation \[VNS\] and ketogenic diet, stable and ongoing for ≥30 days before Visit 1, do not count as AEDs)
. In the Investigator's opinion, parents or caregivers must be able to report accurate seizure assessments during the screening and study periods and subjects must be able to ingest study drug
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The area under the curve (AUC) of carisbamate after a single and multiple doses of carisbamate.
Timeframe: Days 1-3, Day 17
2
The maximum plasma concentration (Cmax) after a single and multiple doses of carisbamate.
. Evidence of clinically significant disease or any medical condition that would compromise the subject's ability to safely complete the study
. Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the investigational medicine product
. Acute disease state (e.g., nausea, vomiting, fever, or diarrhea) within 7 days before Day 1
. Scheduled for surgery during the study
. Ketogenic diet or VNS, unless stable and ongoing for ≥30 days before Visit 1
. Treatment with an investigational drug or device ≥30 days before Visit 1