highly drug-resistant focal epilepsy MedDRA version: 19.0 Level: LLT Classification code 10065337 Term: Focal epilepsy System Organ Class: 100000004852
Conditions
Interventions
Product Name: UCB0942
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: not yet available
Current Sponsor code: UCB0942
Other descriptive name: UCB0942
Concentration unit: mg milligram(s)
C
Sponsors
UCB Biopharma SPRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subject is an adult (18 years of age or more). - 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 take the medication as instructed according to the judgment of the Investigator. - Subject is of normal weight as determined by a body mass index (BMI) between 16.0 and 40.0kg/m2 (exclusive) and with a body weight of at least 50kg (males) or 45kg (females). - Subject fulfills ILAE (1989) criteria for focal epilepsy - Subject has failed to achieve seizure control with =4 appropriately-chosen 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 VNS or other neurostimulation treatments. The VNS must have been in place for at least 12 months with constant settings for at least 3 month. - During the 4 weeks prior to Screening, subject must have reported to have had an average of at least 4 spontaneous and observable focal seizures per week, and cannot have had any seizure-free period longer than 3 days. The cut-off seizure frequency (4 seizures per week) and maximum seizure-free interval (3 days) must be maintained during the 2-week prospective Baseline Period. - Subject has clinical laboratory test results within the reference ranges of the laboratory or isolated test results that are outside the specified ranges and that are deemed as not clinically significant by the Investigator. - Subject has blood pressure and heart rate within normal range in the supine position after 5 minutes rest, or the subject has hypertension that is under partial control with a stable antihypertensive medication regimen but that the Investigator deems as clinically not significant. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 44 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
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 either: >1.5x 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). 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 Case Report form (CRF). If subject has >ULN ALT, AST, or ALP that does not meet the exclusion limit at screening, 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. - 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 had significant blood loss or has donated or received 1 or more units (450mL) of blood within 30 days prior to UCB0942 administration, or has donated plasma or platelets within 14 days prior to UCB0942 administration for this study. - Subject tests positive for human immunodeficiency virus-1/2 antibody (HIV-1/2Ab), hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCV-Ab).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the efficacy of UCB0942 administered concomitantly with each subject's current, stable antiepileptic drug (AED) regimen in subjects who have 4 or more focal seizures with or without secondary generalization per week and who have failed to achieve seizure control with =4 AED regimens of adequate dose and duration. In this protocol, unless otherwise specified, "focal seizures" refers to partialonset seizures of type IA1, IB, and IC, but does not include type IA2, IA3, or IA4 seizures.;Secondary Objective: The secondary objectives are to evaluate the safety and tolerability of UCB0942 and to evaluate the steady-state PK of UCB0942 and its metabolites.;Primary end point(s): 75 % responder rate (75 % RR, proportion of subjects who achieve =75 % reduction in focal seizure frequency);Timepoint(s) of evaluation of this end point: During 2 weeks of the Inpatient Period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Median percent reduction in weekly focal seizure frequency , during 2-weeks of the Inpatient Period • Median percent reduction in weekly focal seizure frequency , during the UCB0942 overall period (approximately 11 weeks) • 75 % responder rate (75 % RR, proportion of subjects who achieve = 75 % reduction in focal seizure frequency) during the last 4 weeks of the Outpatient Maintenance Period • Seizure-free rate during the 2-week Inpatient Period, during 2 weeks of the Inpatient Period • Seizure-free rate during the last 4 weeks of the Outpatient Maintenance Period • Seizure-free rate during the UCB0942 Overall period during UCB0942 Overall period (approximately 11 weeks) • Percentage of seizure free days during the 2-week Inpatient Period, 2 weeks of the Inpatient Period • Percentage of seizure free days during the Outpatient Maintenance Period, during the Outpatient Maintenance Period (approximately 8 weeks) • Number of patients reporting at least one Adverse Event (AE) during the course of the study, all study duration (approximately 19 to 20 weeks) • Number of patients reporting at least one at least one Serious Adverse Event (SAE) during the course of the study, all study duration (approximately 19 to 20 weeks) • Number of subject withdrawals due to Adverse Events (AEs) during the course of the study, all study duration (approximately 19 to 20 weeks);Timepoint(s) of evaluation of this end point: During the complete study at different time points as defined in field Secondary End Point. | — |
Countries
Belgium, Germany, Hungary, Netherlands, Spain
Contacts
Public ContactCT Registries & Results Disclosure
UCB BIOSCIENCES GmbH
Outcome results
None listed