Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age4-55
SponsorSK Life Science, Inc.
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 subjects
Disqualifiers
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
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
Subjects 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
Trial design
Design model
Parallel
Treatments tested in this trial
Carisbamate
DrugAdolescent subjects 12 to 18 years old will receive the same dose as adults. Subjects 4 to \< 12 years old in the carisbamate 200 mg BID arm will receive 4 mg/kg BID (not to exceed 200 mg BID \[or a total of 400 mg per day\]). Subjects 4 to \< 12 years old in the carisbamate 300 mg BID arm will receive 5.5 mg/kg BID (not to exceed 300 mg BID \[or a total of 600 mg per day\]).
Treatment groups
252 Participants
are divided into 4 treatment groupsGroup A: Carisbamate 200 mg BID armExperimental treatment 1 intervention
Group B: Carisbamate 300 mg BID armExperimental treatment 1 intervention
Group C: Placebo matched to 200 mg BID armPlacebo comparator 1 intervention
Group D: Placebo matched to 300 mg BID armPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 YKP509
Time frame
3 yearsSecondary outcomes
1
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 YKP509
Time frame
3 years2
Percentage change from baseline in the frequency of all types of seizures (total seizures) during the double-blind treatment period.
Efficacy of Carisbamate YKP509
Time frame
3 years3
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)
Time frame
3 yearsOther outcomes
1
Percentage change from baseline in the 28-day frequency of: drop seizures (tonic, atonic, tonic-clonic); non-drop seizures (myoclonic seizures, atypical absence); total seizures during the maintenance phase of the double-blind treatment period.
Efficacy of Carisbamate YKP509
Time frame
3 years2
Percentage change from baseline in non-drop seizures (myoclonic seizures, atypical absence) frequency per 28 days during the during the double-blind treatment period.
Efficacy of Carisbamate YKP509
Time frame
3 years3
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 maintenance phase of the double-blind treatment period.
Efficacy of Carisbamate YKP509
Time frame
3 years4
Proportion of subjects with a 75%, 90% and 100% response rate for drop seizures (tonic, atonic, tonic-clonic), non-drop seizures, and total seizures during the double-blind treatment period.
Efficacy of Carisbamate YKP509
Time frame
3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov