Study to Test the Safety and Efficacy of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant Epilepsy
Condition: Drug-Resistant Epilepsy; Focal-Onset Seizures
MeSH terms: Epilepsy; Seizures; Drug Resistant Epilepsy
Intervention: Padsevonil
Intervention description: Pharmaceutical Form: film-coated tablet
Route of Administration: Oral use
Intervention MeSH terms: Padsevonil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 406.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug-Resistant Epilepsy; Padsevonil

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 Criteria:

          -  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 Subjects will be withdrawn from the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 Criteria:

          -  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