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

Phase 1

• Conditions: highly drug-resistant focal epilepsy; MedDRA version: 18.1Level: LLTClassification code 10065337Term: Focal epilepsySystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-003330-12-ES
• Lead Sponsor: CB Biopharma SPR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-30
• Last Update Posted: 4 September 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 46

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 18.0 and 35.0kg/m2 (exclusive), 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 months.
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

Subject has participated in another study of an investigational medication (or medical device) within the last 30 days or is currently participating
Subject has a history of liver disease, including but not limited to, stable (on repeat testing) elevation of liver enzymes ([ALT] or [AST], >1.5 times ULN or [ALP] >2 times ULN).
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).
Subject has a medical condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject?s safety or his/her ability to participate in this study.
Subject has 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 and MINI.
Subject has a history of status epilepticus or has been hospitalized for status epilepticus within the 6-month period prior to Screening Visit.
Subject has had EEGs showing a pattern not consistent with a diagnosis of focal epilepsy (eg, generalized spike-wave).
?Subject only has seizures that are uncountable due to clustering.
Subject has had pseudoseizures, conversion disorder, or other nonepileptic ictal events that in the opinion of the Investigator could be confused with seizures.
Subject had epilepsy surgery <1 year or an epilepsy dietary therapy initiated < 3 months prior to Screening.
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 had intolerable or serious psychiatric side effects with a previous exposure to LEV or BRV.
Subject has a history in the last 5 years of drug or alcohol dependency or tests positive for drugs of abuse or alcohol during screening.
Subject has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response (Yes) to either Question 4 or Question 5 of the C-SSRS at Screening.
Subject has a clinically significant abnormality on ECG that, in the opinion of the Investigator, increases the risks associated with participating in the study.
QT corrected for heart rate using Bazett?s formula (QTcB) or QT corrected

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified