A study of UCB0942 in adult patients with highly drug-resistant focal epilepsy

Phase 1

Conditions: highly drug-resistant focal epilepsy
MedDRA version: 21.1Level: LLTClassification code 10065337Term: Focal epilepsySystem Organ Class: 100000004852
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2014-003330-12-IT

Lead Sponsor: CB Biopharma SR

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 55

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.
·A written ICF approved by the or Independent Ethics Committee (IEC) 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. A separate ICF should be signed and dated by the subject to allow for the optional DNA, mRNA, and lipidomics/proteomics/additional blood biomarker samples.
·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 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: - 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.
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

·Subject has past or present substance abiuse/dependence that in the opinion of the investiagator could threaten the subject's safety within the study,affect the subject's ability to fully participate in the study,or confound study interpretation.·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<1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's
syndrome (ie, direct bilirubin <35%).For randomized 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 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).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 partial on set 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<br>;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 Outcome Measures

Name	Time	Method

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