Randomized, Double-blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy iā¦ (NCT04557085) | Clinical Trial Compass
UnknownPhase 3
Randomized, Double-blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in POS
China, Japan, South Korea540 participantsStarted 2021-03-08
Plain-language summary
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, adjunctive therapy study in subjects with POS, with optional OLE. The study consists of 4 periods as follows: An 8-week of Screening/Baseline Period, 24-week of Double-blind Treatment Period (including a 18-week Titration Phase and 6-week Maintenance Phase), 52-week of Open-label Extension (OLE) Period (applicable for subjects who participate in the OLE) and up to 5-week of End of Study (EOS) Follow-up Period.
The purpose of this study is to evaluate the efficacy and safety of 100, 200 and 400 mg/day of cenobamate as adjunctive therapy compared with placebo in subjects with partial onset seizures (POS).
The study will also evaluate the long-term safety and tolerability of cenobamate adjunctive therapy in subjects with POS who have completed the double-blind treatment period.
Who can participate
Age range18 Years ā 70 Years
SexALL
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Inclusion criteria
ā. Male or female subject and age 18 to 70 years inclusive at the time of signing the informed consent
ā. Weight at least 35 kg
ā. Written informed consent signed by the subject prior to entering the study in accordance with the ICH GCP guidelines. For subjects who lack the capacity, consent will be obtained from the parent/legal guardian. For all underaged subjects according to the specific laws of the country, both the written consent of the subject and the consent of the parent/legal guardian will be obtained.
ā. A diagnosis of partial onset seizures according to the International League Against Epilepsy's Classification of Epileptic Seizures (1981). Diagnosis should have been established by clinical history and an electroencephalogram (EEG).
ā. EEG performed within 5 years prior to Visit 1 that is consistent with localization related epilepsy; normal interictal EEGs will be allowed provided that the subject meets the other diagnosis criterion (i.e., clinical history). For chronic patients for which the current diagnosis is not very clear, additional EEG results older than 5 years but within 10 years may be used for final confirmation of epilepsy diagnosis.
ā. Need additional antiepileptic drug (AED) treatment despite having been treated with at least one AED for the last 2 years.
ā. During the 8-week Screening/Baseline Period, subjects must have at least 8 partial seizures including only simple partial seizures with motor component, complex partial seizures, or secondarily generalized seizures without a seizure-free interval of greater than 25 days any time during the 8-week period. Subjects must have at least 3 of these partial seizures during each of the two consecutive 4-week segments of the Screening/Baseline Periods, respectively.
What they're measuring
1
Percent change from baseline in seizure frequency (seizure rate per 28-day interval) of all simple partial motor, complex partial, or secondarily generalized seizures during the Maintenance Phase.
Timeframe: per 28 days during 6 week maintenance phase
ā. Currently on stable antiepileptic treatment regimen:
Exclusion criteria
ā. Female subjects who are pregnant (or planning to become pregnant during the study), lactating or breast-feeding
ā. History of non-epileptic or psychogenic seizures
ā. Presence of only non-motor simple partial seizures or primary generalized epilepsies
ā. History of seizure clusters (episodes lasting less than 30 minutes in which multiple seizures occur with such frequency that the initiation and completion of each individual seizure cannot be distinguished) within 6 months prior to Visit 1
ā. Presence or previous history of Lennox-Gastaut syndrome
ā. Scheduled epilepsy surgery within 8 months of Visit 1
ā. Evidence of any clinically significant laboratory abnormalities or disease (e.g., psychiatric, behavioral problems, cardiac, respiratory, gastrointestinal, hepatic \[liver transaminases, ALT or AST, more than twice the upper limit of normal (ULN) or total or direct bilirubin not within normal limits\], or renal disease) that, in the opinion of the Investigator, could affect subject's safety or conduct of the study.
ā. Any clinically significant active central nervous system (CNS) infection, demyelinating disease, degenerative neurologic disease, or any CNS disease deemed to be progressive during the course of the study that may confound the interpretation of the study results