A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE FINDING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PADSEVONIL AS ADJUNCTIVE TREATMENT OF FOCAL-ONSET SEIZURES IN ADULT SUBJECTS WITH DRUG-RESISTANT EPILEPSY
- Conditions
- Epilepsy and epilepsy syndrome
- Registration Number
- JPRN-jRCT2080224509
- Lead Sponsor
- CB Japan Co., Ltd.
- Brief Summary
The primary efficacy variable, the change in observable focal-onset seizure frequency from Baseline over the 12-week Maintenance Period, was not statistically significant compared with placebo in any PSL dose group. Overall, PSL was generally well tolerated and the safety profile was as expected, based on the pharmacology of the AED, and was consistent with previous experience with PSL.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 411
1) Subject fulfills diagnostic criteria for epilepsy and has observable focal-onset (IA1, IB, and IC) seizures for at least 3 years at the time of enrolment (according to the ILAE Classification of Epileptic Seizures, 1981)
2) Subject is currently treated with an individually optimized and stable dose of at least 1 and up to 3 AEDs for the 8 weeks prior to the Screening Visit (Visit 1).
3) Subjects having on average 4 and more spontaneous and observable focal-onset seizures per 28 days.
1) Subject has a history of or signs of generalized or combined generalized and focal epilepsy
2) Subject has a history of status epilepticus within the 6-month period prior to Screening Visit (Visit 1).
3) Subject has seizures on a regular basis that are uncountable eg due to clustering during the 8-week retrospective Baseline and during the 4-week Baseline Period.
4) Subject is currently treated with carbamazepine, phenytoin, primidone, or phenobarbital.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method