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 range2 Years
SexALL
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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
✕. Progressive neurological disease
✕. Prior treatment with carisbamate
✕
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