Intervention: Padsevonil
Trial phase: Phase 2
SMILES: COCc1nn2c(CN3C[C@@H](CC(F)(F)Cl)CC3=O)c(C(F)(F)F)nc2s1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: All enrolled participants continued the same UCB0942 dose which they were receiving during last visit of study EP0069 and the dose could be further increased or decreased in participants to optimize the drug tolerability and seizure control for each participant. Daily UCB0942 film-coated tablets were administered orally in doses of 100 mg (50 mg bid), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid) for up to approximately 5 years. Participants formed the Safety Set (SS).
Eligibility criteria:
Inclusion Criteria:

A written Informed Consent form approved by the Independent Ethics Committee is signed and dated by the subject, after the Investigator assesses whether the subject is able to understand the potential risks and benefits of participating in the study
Subject must have completed Visit 13 (V13) of the Outpatient Maintenance Period of EP0069 to be eligible for enrollment into EP0073
In EP0069, the subject demonstrated a reduction in frequency and/or severity of seizures as compared to baseline that is considered clinically significant by the Investigator and significant by the subject
In EP0069, the subject experiences substantial benefit from UCB0942 with acceptable tolerability according to the subject and Investigator
No tolerability issues that can outweigh attained benefits, in the opinion of the Investigator
Female subjects of nonchildbearing potential (premenarcheal, postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, and complete hysterectomy) are eligible. Female subjects of childbearing potential are eligible if they use medically accepted contraceptive methods
Male subject confirms that, during the study period and for a period of 3 months after the final dose, when having sexual intercourse with a woman of childbearing potential, he will use a barrier contraceptive (eg, condom)Exclusion Criteria:
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. The subject should be referred immediately to a Mental Healthcare Professional and must be withdrawn from the study
Subject has taken other (non-Anti-Epileptic Drug) prescription, non-prescription, dietary (eg, grapefruit or passion fruit), or herbal products that are potent inducers or inhibitors of the CYP3A4 pathway for 2 weeks (or 5 half lives whichever is longer) prior to study entry

Subject has an abnormality in the 12-lead electrocardiography that, in the opinion of the Investigator, increases the risks associated with participating in the study. In addition, any subject with any of the following findings will be excluded:

Prolonged QTc (Bazett's, machine-read) interval defined as > 450 ms for males and > 470 ms for females
Bundle branch blocks and other conduction abnormalities other than mild first degree atrioventricular block (defined as PR interval >= 220 ms)
Irregular rhythms other than sinus arrhythmia or occasional, rare supraventricular or rare ventricular ectopic beats
In the judgment of the Investigator, T-wave configurations are not of sufficient quality for assessing QT interval duration
Subject has a clinically significant abnormality on echocardiography at the Entry Visit (V2) of EP0073

Upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >ULN total bilirubin (>=1.5xULN total bilirubin if known Gilbert's syndrome) at the EV (V2) of EP0073 (V15 of EP0069). If subject has elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's syndrome (ie, direct bilirubin <35%). For enrolled subjects with a baseline result

ULN for ALT, AST, ALP, or total bilirubin, a baseline diagnosis and/or the cause of any clinically meaningful elevation must be understood and recorded in the electronic Case Report form (eCRF). If subject has >ULN ALT, AST, or ALP that does not meet the exclusion limit at screening (ie, the value is
ULN but <=2xULN at the EV [V2] of EP0073), repeat the tests, if possible, prior to dosing to ensure there is no further ongoing clinically relevant increase. In case of a clinically relevant increase, inclusion of the subject must be discussed with the Medical Monitor