epileptic seizures focal epilepsy
Conditions
Interventions
Please refer to the section 'study design'
Sponsors
UCB Biopharma SRL
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Subject must have completed 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 acceptabletolerability according to the subject and Investigator. - 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
Exclusion criteria: - Subject has developed a known hypersensitivity to any components of the investigational medicinal product (IMP) as stated in this protocol during participation in EP0069. - Subject has any severe medical, neurological, or psychiatric condition, or laboratory value which may have an impact on the safety of the subject. - Subject is a woman who is pregnant or lactating. - 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 C-SSRS. The subject should be referred immediately to a Mental Healthcare Professional and must be withdrawn from the study. - Subject has taken other (non-AED) 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 ECG 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 >450ms for males and >470ms for females * Bundle branch blocks and other conduction abnormalities other than mild first degree atrioventricular block (defined as PR interval *220ms) * 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 EV (V2) of EP0073. - 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 (*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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - To evaluate the long-term safety and tolerability of UCB0942 at individualized doses between 100mg/day to a maximum of 800mg/day in subjects with highly drug-resistant focal epilepsy. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To evaluate the long-term efficacy of UCB0942 - To evaluate the effects of UCB0942 on the subject*s quality of life. | — |
Countries
Netherlands
Outcome results
None listed