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Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
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
Exclusion criteria
Eligibility
Age eligible for study : 4 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2022-04-28
Primary completion: 2025-06-01
Study completion finish: 2026-06-01
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT05219617
Intervention or treatment
DRUG: Carisbamate
Conditions
- • Seizures
- • Lennox Gastaut Syndrome
Find a site
Closest Location:
Austin Hosptial
Research sites nearby
Select from list below to view details:
Austin Hosptial
Heidelberg, Not Specified, Australia
Alfred Health
Melbourne, Not Specified, Australia
Perth's Children Hospital
Nedlands, Not Specified, Australia
Queensland Children's Hospital
South Brisbane, Not Specified, Australia
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/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Carisbamate 200 mg BID arm
| DRUG: Carisbamate
|
EXPERIMENTAL: Carisbamate 300 mg BID arm
| DRUG: Carisbamate
|
PLACEBO_COMPARATOR: Placebo matched to 200 mg BID arm
| DRUG: Carisbamate
|
PLACEBO_COMPARATOR: Placebo matched to 300 mg BID arm
| DRUG: Carisbamate
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time 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 YKP509 | 3 years |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time 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 YKP509 | 3 years |
Percentage change from baseline in the frequency of all types of seizures (total seizures) during the double-blind treatment period. | Efficacy of Carisbamate YKP509 | 3 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 |
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