Status:
TERMINATED
Study to Test the Safety and Efficacy of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant Epilepsy
Lead Sponsor:
UCB Biopharma SRL
Conditions:
Drug-Resistant Epilepsy
Focal-Onset Seizures
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of the study is to evaluate the long-term safety and tolerability of Padsevonil administered at individualized doses as adjunctive treatment for subjects with drug-resistant epilepsy.
Eligibility Criteria
Inclusion
- Subject is an adult (18 years of age or more )
- Subject with epilepsy who has completed 1 of the previous Padsevonil (PSL) studies which allow access to the present study
- Female subjects of child bearing potential must have a serum negative pregnancy test at the Entry Visit, which is confirmed to be negative by urine testing prior to further dispensing at each study visit thereafter. Subjects will be withdrawn from the study as soon as pregnancy is known. Female subjects will use an efficient form of contraception for the duration of the study and for a period of 3 months after their final dose of PSL.
Exclusion
- Subject has any severe medical, neurological, or psychiatric condition, or laboratory value which may have an impact on the safety of the subject
- Subject has active suicidal ideation as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the 'Since Last Visit' version of the Columbia-Suicide Severity Rating Scale (C-SSRS)
- Subject has \>2x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or \>ULN total bilirubin (\>= l.5x ULN total bilirubin if known Gilbert's syndrome) at the Entry Visit
- Subject has a clinically-significant abnormality on electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
- Subject has an abnormality on echocardiogram at last echocardiogram assessment, or foreseen in parent study as assessed by central reader that is accompanied by clinical symptoms or a Grade 2\* (or higher)/moderate severity abnormality, or a history of rheumatic heart disease, or other known valvular abnormalities (\*according to the ASE Guidelines, 2017; Zoghbi et al 2017)
- Female subject who plans to be pregnant or is breastfeeding
Key Trial Info
Start Date :
August 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2020
Estimated Enrollment :
406 Patients enrolled
Trial Details
Trial ID
NCT03370120
Start Date
August 27 2018
End Date
December 11 2020
Last Update
December 29 2021
Active Locations (156)
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1
Ep0093 839
Chandler, Arizona, United States, 85226
2
Ep0093 815
La Jolla, California, United States, 92037
3
Ep0093 801
San Francisco, California, United States, 94115
4
Ep0093 803
Honolulu, Hawaii, United States, 96817