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Safety and Efficacy Study of Cenobamate in Pediatric Subjects 2-17 Years of Age With Partial-onset (Focal) Seizures
Primary objective: To evaluate the safety and tolerability of cenobamate in pediatric subjects 2-17 years of age with partial-onset (focal) seizures.
Study details:
Secondary objectives:. * To evaluate the efficacy of cenobamate tablets and suspension in pediatric subjects with partial onset (focal) seizures. * To evaluate the pharmacokinetics of cenobamate tablets and suspension in pediatric subjects with partial onset seizures.
* To evaluate the PK/pharmacodynamics of cenobamate in pediatric subjects with partial onset (focal) seizures. * Acceptability and palatability assessment (determined by a 5-point Hedonic Scale) of the oral formulation and the 12. 5 mg tablets - Day 1, and Day 15.
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 : 2 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2022-01-14
Primary completion: 2026-05-01
Study completion finish: 2026-07-01
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT05067634
Intervention or treatment
DRUG: Xcopri
Conditions
- • Partial Epilepsy
Find a site
Closest Location:
Royal Children's Hospital Melbourne
Research sites nearby
Select from list below to view details:
Royal Children's Hospital Melbourne
Parkville, Not Specified, Australia
Austin Health
Heidelberg, Not Specified, Australia
Sydney Children's Hospital - Randwick
Randwick, Not Specified, Australia
Children's Health Queensland Hospital and Health Service
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: 12 to < 18 year olds
| DRUG: Xcopri
|
EXPERIMENTAL: 6 to <12 years old
| DRUG: Xcopri
|
EXPERIMENTAL: 4 to <6 years old
| DRUG: Xcopri
|
EXPERIMENTAL: 2 to <4 years old
| DRUG: Xcopri
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Incidence of Adverse Events and SAEs | Summary statistics for clinical laboratory test results and vital signs; and physical examination, neurologic examination and electrocardiogram (ECG) finding.of age with partial-onset (focal) seizures | 3 Years |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
To collect plasma samples of cenobamate to support the evaluation of the pharmacokinetics of cenobamate tablets and suspension in pediatric subjects with partial onset (focal) seizures | The area under the curve (AUC) of Xcopri after a single and multiple doses of Xcopri | 3 Years |
Acceptability and palatability assessment (determined by a 5-point Hedonic Scale) of the oral formulation and tablets | Testing to determine how patients respond to the taste and route of Xcopri | 3 Years |
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