A 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; UCB0942; Placebo
Intervention description: Active substance: UCB0942 Pharmaceutical form: Film-coated tablet Concentration: 200 mg Route of Administration: Oral use; Active substance: UCB0942 Pharmaceutical form: Film-coated tablet Concentration: 100 mg Route of Administration: Oral use; Pharmaceutical form: Film-coated tablet Route of administration: Oral use
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: UCB0942; Treatment-resistant focal epilepsy; Partial seizures; Seizure therapy

Summary:

      This study is to assess the efficacy, safety, and tolerability of the investigational drug
      UCB0942in adult subjects with drug-resistant focal epilepsy across multiple centers in
      Europe.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is an adult (18 years of age or more)

          -  Subject is able to understand the study and the ICF as assessed by the Investigator.
             Subjects with known mental retardation (defined as IQ below 70) are not eligible to
             participate. Subject and/or caregiver is considered reliable and capable of adhering
             to the protocol (eg, able to understand and complete diaries), visit schedule, and the
             medication intake scheme as instructed according to the judgment of the Investigator

          -  Subject fulfills ILAE (1989) criteria for focal epilepsy; clinical semiology should be
             described and fulfill criteria for focal seizures; there will have been an
             electroencephalogram (EEG) reading compatible with focal epilepsy in the last 5 years;
             the subject has no seizures that are not focal by the new ILAE criteria; a brain MRI
             (magnetic resonance imaging) or head CT (computed tomography) to be performed before
             randomization, if no such scan was performed in the last 5 years, and a report is
             available. If a scan was performed within the last 5 years but the epilepsy has not
             been stable since the last scan, a new scan should be obtained

          -  Subject has failed to achieve seizure control with ≥4 appropriately chosen
             Antiepileptic Drug (AED) regimens of adequate dose and duration, including the current
             treatment, as documented in medical records and per Investigator assessment of patient
             report

          -  Subject is currently treated with a stable dose of at least 1 AED for the 4 weeks
             prior to the Screening Visit (Visit 1) and throughout the duration of the Treatment
             Period with or without additional concurrent vagus nerve stimulation (VNS) or other
             neurostimulation treatments. The VNS must have been in place for at least 12 months
             with constant settings for at least 3 months and the battery life of unit anticipated
             to extend for the duration of study prior to the Screening Visit and throughout the
             duration of the study

          -  During the 4 weeks prior to Screening (Historical Baseline Period), subject must
             report to have had an average of at least 4 spontaneous and observable focal seizures
             per week ("focal seizures" refers to partial-onset seizures of type IA1, IB, and IC,
             but does not include type IA2, IA3, or IA4 seizures), and cannot have had any
             seizure-free period longer than 3 days (based on Investigator assessment of subject
             report and seizure diaries if available). The cut-off seizure frequency (4 seizures
             per week) and maximum seizure-free interval (3 days) must be maintained during the
             2-week Prospective Outpatient Baseline Period

          -  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. Oral or depot contraceptive treatment with
             at least ethinylestradiol 30 μg per intake used with an additional barrier
             contraception method, monogamous relationship with vasectomized or female partner, or
             double-barrier contraception are acceptable methods. The subject must understand the
             consequences and potential risks of inadequately protected sexual activity, be
             educated about and understand the proper use of contraceptive methods, and undertake
             to inform the Investigator of any potential change in status. Abstinence will be
             considered as an acceptable method of contraception if the Investigator can document
             that the subject agrees to be compliant when it is in line with the preferred and
             usual lifestyle of the subject

          -  Male subjects confirm 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) and that the respective partner will
             use an additional contraceptive method

        Exclusion Criteria:

          -  Subject has participated in another study of an investigational medication (or medical
             device) within the last 30 days or is currently participating in another study of an
             investigational medication (or a medical device)

          -  Subject has a known hypersensitivity to any components of UCB0942 formulation or to
             similar drugs (LEV, BRV, or benzodiazepines), or a history of drug or other allergy
             that, in the opinion of the Investigator or UCB Study Physician, contraindicates
             her/his participation

          -  Subject has a current or past psychiatric condition that, in the opinion of the
             Investigator, could compromise his/her safety or ability to participate in this study
             including a history of schizophrenia, schizoaffective disorder, bipolar disorder, or
             severe unipolar depression. The presence of potential psychiatric exclusion criteria
             will be determined based on screening with the BPRS plus the Mini International
             Neuropsychiatric Interview (MINI)

          -  Subject has taken other (non-AED) prescription, nonprescription, 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 the Baseline Visit

          -  Subject is currently treated with carbamazepine, phenytoin, primidone, or
             phenobarbital or any other drug known to induce CYP3A4 liver enzymes; Subject is
             taking tiagabine, felbamate, or vigabatrin; Subject is taking benzodiazepines,
             zolpidem, zaleplon, or zopiclone >3 times per week for any indication

          -  Subject has a clinically significant abnormality on echocardiography at Screening or a
             history of rheumatic heart disease or other known valvular abnormalities

          -  Subjects with a history of hypersensitivity reactions or autoimmune disease

          -  Female subject who is pregnant or breastfeeding