An Open-label Extension Study of UCB0942 in Adult Patients With Highly Drug-resistant Focal Epilepsy
Condition: Highly Drug-resistant Focal Epilepsy
MeSH terms: Epilepsy; Epilepsies, Partial
Intervention: UCB0942
Intervention description: Active Substance: UCB0942
Pharmaceutical form: Film-coated tablet
Concentration: 25 mg, 100 mg or 200 mg
Route of Administration: oral
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug-resistance; focal epilepsy; partial-onset seizures

Summary:

      The purpose of study EP0073 is to assess the long-term safety, tolerability, and efficacy
      during 5 years of treatment with the drug UCB0942 in patients with highly drug-resistant
      focal epilepsy. Also, the effects of UCB0942 on the patient's quality of life will be
      explored.
    

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:

               1. Prolonged QTc (Bazett's, machine-read) interval defined as > 450 ms for males and
                  > 470 ms for females

               2. Bundle branch blocks and other conduction abnormalities other than mild first
                  degree atrioventricular block (defined as PR interval >= 220 ms)

               3. Irregular rhythms other than sinus arrhythmia or occasional, rare
                  supraventricular or rare ventricular ectopic beats

               4. 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